CARDIOVASCULAR
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Refer to Instructions for Use (IFU) for additional information

Deployment & Suture Management

Device Preparation

Marker Port


To prep the device, verify Marker Lumen patency by flushing it with saline until saline exits the Marker Port.

4 Key Steps to Suture Deployment

Step 1


1. Advance device & lift Lever (Open Foot)

Step 2


2. Maintain retraction and depress Plunger (Deploy Needles)

Step 3


3. Pull back Plunger (Deploy Suture)

Step 4


4. Lower Lever (Close Foot)

Suture Management

Step A

A. Capture blue (rail) suture limb in Suture Gate or Snared Knot Pusher and Advance Suture Knot

Step B


B. Lock Suture Knot by pulling white (non-rail) suture limb

Step C


C. Trim suture limbs by pulling Trimming Lever

Single and Multiple Device Deployment

View the animation library for full deployment steps for single and multiple devices.

 

System Overview

Small Hole Deployment

Large Hole Deployment

Tips and Techniques

Refer to Instructions for Use for additional information.

Foot Break

Causes/Observations

Potential causes during Plunger deployment (Step 2)
  • Rotating/rocking the device or excessive force during Plunger deployment
  • Shallow (less than 45º) Plunger deployment angle

 

 

Potential observations after Plunger removal (Step 3) and/or device removal
  • No Suture or link present
  • Just a link and no Suture present
  • Missing part of Foot when the device is removed
Deployment Angle During plunger deployment (Step 2)
Incorrect angle

  Shallow Deployment Angle

  • Sub-optimal in any tissue conditions
  • Potential gap between Posterior Foot and vessel wall increases chance for foot break and cuff miss
Correct angle

  45º Deployment Angle

  • Ideal in healthy compliant tissue conditions
  • Posterior and Anterior Foot appose evenly to compliant vessel wall

Foot Break Prevention

Footbreak Prevention steps
Footbreak Prevention steps
  1. Position the Perclose™ device at 45º angle and keep stable with the left hand during Plunger deployment
    • The deployment angle may vary slightly depending on anatomy
  2. Maintain even and gentle tension over the Anterior and Posterior Foot against the vessel wall
    • The key is to raise the device until pressure is evenly distributed across the Anterior and Posterior Foot
  3. Press down on the Plunger with a gentle, increasing pressure to advance the Needles
    • The Needles are more susceptible to deflecting off calcification with higher Plunger force and higher Needle speed
Device Removal
Device Removal steps
Device Removal steps


Before attempting to remove the device:

  • Relax the device before pushing the Lever down
  • Push the Lever down to return Foot to the closed position

Device Entrapment

Observations

Difficult or unable to lower the Lever (close the Foot) and remove device after the Suture Deployment

 

Causes & Prevention

Potential Causes Prevention
  1. Separation of Proximal Guide & Distal Guide due to excessive pressure buildup during device advancement
  • If excessive resistance is felt during device advancement, gently roll device medially and laterally to ease device entry.
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation prior to Step 1 (before Open Foot)
  • Only rotate device up to 30°  from the 12 o’clock position, especially in diseased non-compliant tissue conditions.
  1. Separation of Proximal Guide & Distal Guide due to excessive device rotation after Step 1 (with Open Foot)
  • Complete device rotation, if necessary, before performing Step 1 (Open Foot).
  1. Malfunction of Lever-Foot wire control mechanism due to excessive retraction force during suture deployment
  • Maintain gentle retraction against the vessel wall when depressing Plunger to deploy needles (Step 2).
  • Relax device when lowering Lever (Step 4) to close the Foot.
  • Advance device slightly to restore marker flow, if necessary, before lowering the Lever.
  1. Unable to close Foot due to tissue interference between Distal Guide and Posterior Foot
  • Stop device advancement once “mark” is observed from the Marker Lumen to ensure the Foot is open (Step 1) near or at the access site to minimize intraluminal travel during pull back for Step 2

Cuff Miss

Cuff Miss
No suture or link present
Cuff Miss
Cuff and link present, no Suture
  • Plunger is withdrawn and no Suture is present. The link may or may not be attached to Anterior Needle
  • Tip(s) of Needle(s) did not lock with Cuff(s)

Potential Causes

Cuff Miss
Cuff Miss
  • Tissue too thick and the Needle(s) cannot lock with Cuff(s); certain anatomical conditions such as heavily calcified arteries or scarred tissue.
  • Incomplete advancement of Plunger; black Collar on Plunger did not contact Body of Perclose™ device.
  • Changing the angle, rotating or rocking the device may make the Needles more susceptible to deflection.
  • Not stabilizing device or maintaining the device at 45º throughout deployment and retraction of Plunger/Suture.

Prevention/Resolution

Cuff Miss Prevention
Cuff Miss Resolution
Cuff Miss Resolution

Prevention
  • Proper patient selection
  • Deploy device at 45º angle
  • Maintain gentle retraction against the vessel wall
  • Stabilize device with left hand during Plunger deployment
  • Ensure black Collar on Plunger contacts the device Body
  • Maintain and stabilize the device at 45º angle throughout removal of Plunger/Needles and until Suture is fully retracted
     
Resolution
  • Insert wire and exchange for another device

Suture Break

Causes/Prevention

 

 

  • Suture may look thin and elongated
  • Rail or non-rail limbs can break
Suture Break Prevention

 

  • Load Suture at mid-point of Suture Trimmer (Do not load at tip)
  • Keep Thumb Knob retracted until Suture limbs drop into Suture Gate (Do not close Suture Gate on the Suture)
Suture Break Prevention
  • Keep Thumb Knob toward ceiling (Do not rotate Suture Trimmer)
  • Keep suture limbs coaxial to Suture Trimmer and tissue tract at all times
  • Do not pull laterally or medially on Suture
  • Apply slow, consistent, increasing tension (Avoid quick, jerky movements)

Poor Flow

Poor Arterial Flow / No Flow

Poor Flow Arterial
Poor Flow Arterial
Poor Flow Arterial

Resolution

Marker Port against vessel wall
  • Do not deploy Perclose™ devices with vessel diameters <5 mm
     
Side wall stick
  • Gently rotate device to move Marker Port off vessel wall
     
Low blood pressure
  • Slow drip is acceptable if Perclose™ device position is confirmed
     
Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
     
Device not in vessel lumen
  • Drip can occur when Marker Port is near vessel lumen but not completely in the vessel, especially with high blood pressure or 7/8F sheaths
  • Continue advancing the Perclose™ device until brisk pulsatile flow is observed

Poor Venous Flow / No Flow

Poor Flow Arterial
Poor Flow Arterial
Poor Flow Arterial

Resolution

No flow is possible and acceptable if device location is confirmed
  • Apply pressure on groin or lower abdomen
  • Inject contrast through Marker Lumen
  • Use ultrasound to confirm location of device
  • Have the patient perform the Valsalva maneuver
     
Marker Port against vessel wall
  • Small vessel diameter; if not 5 mm vessel, do not deploy
     
Side wall stick
  • Gently rotate device to move Marker Port off vessel wall
     
Low blood pressure
  • Slow drip is acceptable in vein
     
Clot or tissue plugging Marker Port
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
     
Device not in vessel lumen
  • No flow can occur when Marker Port is near vessel lumen but not completely in the vessel
  • Continue inserting device until slow drip occurs

Lack of Hemostasis

Lack of hemostasis may be a result of incorrect order of knot advancement or tangled sutures.

Incorrect Order of Knot Advancement
Poor Flow Arterial
  • Advance Sutures in the order of deployment
Poor Flow Arterial
Poor Flow Arterial
  • First Suture deployed is on the "bottom" or closest to the vessel. If Second Suture is tightened out of order, it may result in tangled Sutures and/or the inability to tighten the First Suture successfully
Poor Flow Arterial
  • After initial knot advancement of all Sutures, continue to tighten and lock each knot in the order deployed
  • Tightening and locking the Second Suture before the First Suture is completely secure can result in an incomplete or "partial" close
Tangled Sutures

 

  • After Suture Deployment, a clamp is immediately placed on the Suture limbs. A gentle retraction is placed on the clamp until the Suture is taut. This removes all Suture slack from the tissue tract


  • If Suture slack is not removed, the Sutures can become tangled or pushed into the vessel during insertion of procedural sheaths and device exchanges

MAT-2103455 v1.0

Important Safety Information

IMPORTANT SAFETY INFORMATION
 

rx-only-logo  Perclose™ ProStyle™ Suture-Mediated Closure and Repair System

 

Indications: The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access sites of patients who have undergone diagnostic or interventional catheterization procedures.

The Perclose™ ProStyle™ SMCR System is used without or, if required, with adjunctive manual compression.

For access sites in the common femoral artery using 5F to 21F sheaths.

For access sites in the common femoral vein using 5F to 24F sheaths.

For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

CAUTION:Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.

Contraindications: There are no known contraindications to the use of this device.

Warnings: Do not use the Perclose™ ProStyle™ SMCR System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose™ ProStyle™ SMCR System is intended for single use only.

Do not use the Perclose™ ProStyle™ SMCR System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.

Do not use the Perclose™ ProStyle™ SMCR System in arterial access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System in venous access if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the vessel.


Precautions:

  • Prior to use, inspect the Perclose™ ProStyle™ SMCR System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.
  • As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose™ ProStyle™ SMCR System. Employ appropriate groin management, as per hospital protocol, post procedure, and post hospital discharge to prevent infection.
  • Use a single wall puncture technique. Do not puncture the posterior wall of the vessel in arterial access.
  • Do not deploy the Perclose™ ProStyle™ Device at an angle greater than approximately 45 degrees, as this may cause a cuff miss.
  • There are no reaccess restrictions if previous arteriotomy / venotomy repairs were achieved with Abbott Medical SMC or SMCR systems.
  • If significant blood flow is present around the Perclose™ ProStyle™ SMCR Device, do not deploy needles. Remove the device over a 0.038" (0.97 mm) (or smaller) guide wire and insert an appropriately sized introducer sheath.
  • Prior to pushing the plunger to advance the needles, stabilize the device by the body to ensure the foot is apposed to the vessel wall and the device does not twist during deployment. Twisting (torquing) of the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  • Do not apply excessive force to the lever when returning the foot to its original position down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  • Do not advance or withdraw the Perclose ProStyle SMCR Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the Perclose ProStyle SMCR Device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  • If excessive resistance in advancing the Perclose™ ProStyle™ SMCR Device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guide wire and reinsert the introducer sheath or use manual compression.
  • Remove the Perclose™ ProStyle™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.
  • Care should be taken to avoid damage to the suture from handling. Avoid crushing damage due to application of surgical instruments such as clamps, forceps or needle holders.
  • For catheterization procedures using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
  • For catheterization procedures using a procedural sheath > 8F, use manual compression, compression assisted devices, surgical repair, and / or other appropriate treatment methods in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
  • For catheterization procedures using a procedural sheath > 8F, where the operating physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary vascular surgical intervention.



Potential Adverse Events: Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to device components
  • Vascular access complications which may require transfusion or vessel repair, including:
    • Anemia
    • Aneurysm
    • Arteriovenous fistula
    • Bleeding / hemorrhage / re-bleeding
    • Bruising / hematoma
    • Embolism
    • Inflammation
    • Intimal tear / dissection
    • Perforation
    • Pseudoaneurysm
    • Retroperitoneal hematoma / bleeding
    • Scar formation / calcification
    • Wound dehiscence
  • Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
    • Atrial arrhythmias
    • Ventricular arrhythmias
  • Femoral artery / venous complications which may require additional intervention, including:
    • Arterial / venous stenosis
    • Arterial / venous occlusion
    • Arteriovenous fistula
    • Intimal tear / dissection
    • Ischemia distal to closure site
    • Nerve injury
    • Numbness
    • Thrombus formation
    • Vascular injury
  • Peripheral ischemic conditions (including deep vein thrombosis,
  • pulmonary embolism, post-procedure pulmonary embolism):
    • Deep vein thrombosis
    • Pulmonary embolism
  • Infection:
    • Infection / sepsis
  • Pain
  • Hemodynamic instability:
    • Hypotension / hypertension
    • Vasovagal episode
  • Death
  • Device complications
  • Device failure
  • Device malfunction

MAT-2103461 v1.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.