PRODUCT ADVISORIES ARCHIVE

Physician Communication

On March 30, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely.  Please find the below physician communication document with patient management recommendations for further information.

Physician Communication

On March 7, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover. Please find the below physician communication document with patient management recommendations for further information.

Physician Communication

On November 20, 2018, Abbott provided an Urgent Medical Device Correction notice to customers communicating a voluntary recall of a small number of Confirm Rx™ DM3500 Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app. Please find the below physician communication document for further information.

Physician Communication

On October 17, 2018, Abbott provided an update to physicians on the previously communicated Class I Recall associated with the HeartMate 3™ Left Ventricular Assist System. Abbott has received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice. The Outflow Graft Clip is now available.

On May 22, 2018, FDA classified this medical device advisory as a Class I Recall. Abbott provided a Frequently Asked Questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.

On May 21, 2018, Abbott provided an update to the Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

On April 5, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

Physician Communication

On September 5, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support. This communication is to remind our physician and hospital partners of the importance of following the proper method for exchanging the CentriMag™ Acute Circulatory Support System Motor (Model# 102956) in the event the system experiences an interruption of power.

Physician Communication

On June 14, 2018, Abbott provided an Urgent Medical Device Recall notice to hospitals, clinics and patients communicating that a small number of CardioMEMS™ Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a false Error 5 message due to an incorrectly configured component within the device electronics. Please find the below patient and hospital communication documents for further information.

Physician Communication

May 18, 2018 – Abbott recently notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx™  Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin™ programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.

Physician Communication

April 16, 2018 – Abbott recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade includes improved cybersecurity protection and an update to provide device based premature battery depletion detection in certain HV devices.

Patient Communication

Abbott has developed online information for patients, located here. The page includes important information about the update and responses to frequently asked questions from patients.

Physician Communication

April 16, 2018 – Abbott recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).

As communicated in August 2017, the Battery Performance Alert (BPA) algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion. Until now, detection of this alert has only been available through the Merlin.net™ remote monitoring system and the Merlin™ programmer during routine follow-up evaluations. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. travel). Additionally, an alert will still continue to be provided to physicians through the Merlin.net™ remote monitoring system and the Merlin™ programmer during subsequent follow-up.

August 29, 2017 – As part of Abbott’s commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.

The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the October 11, 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™.

On October 11, 2016, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical ICD and CRT-D devices manufactured before May 23, 2015 for models Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™ :

Patient Communication

April 16, 2018 Update – Abbott has developed online information for patients, located here. The page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.

Physician Communication

On April 05, 2018, Abbott provided an update regarding the investigation of the Nanostim™ Leadless Cardiac Pacemaker Study (LCP) detached docking button.

On November 17, 2017, Abbott provided a Dear Doctor Letter to physicians regarding the Nanostim™ Leadless Cardiac Pacemaker.

Physician Communication

On August 29, 2017, Abbott provided an update to physicians with information on a pacemaker firmware update for Abbott pacemaker models which include the RF telemetry versions of the following devices in the U.S.: Accent SR RF™, Accent MRI™, Assurity™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™ and Quadra Allure MP RF™.

Physician Communication

On October 28, 2016, St. Jude Medical provided an Important Medical Device Information communication to physicians regarding the Nanostim™ Leadless II IDE/CAP Study:

Physician Communication

On November 3, 2015, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Optisure™ Dual Coil HV Leads:

On January 22, 2016, St. Jude Medical provided an Important Medical Device Advisory update to physicians regarding the Optisure™ Dual Coil HV Leads:

Physician communication

On August 18, 2015, St. Jude Medical provided an Important Medical Device Correction Update to physicians regarding the Merlin@home™ RF Monitoring Transmitter Model EX1150:

On December 18, 2014, St. Jude Medical provided an Important Medical Device Correction to physicians regarding the Merlin@home™ RF Remote Monitoring Transmitter Model EX1150:

Physician Communication

On August 19, 2014, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the Ellipse™ and Ellipse™ ST VR/DR Implantable Cardioverter Defibrillators (ICDs):

Patient Communication

Physician communication

Considerations When Using Electrocautery in Patients Implanted with Older Generation St. Jude Medical™ Pacemakers (Affinity™, Entity™, Integrity™, Identity™, Sustain™, Frontier™, Victory™ and Zephyr™ models)

Physician communication

On April 3, 2012, St. Jude Medical provided a Medical Device Advisory and Important Product Information Update to physicians regarding the QuickSite™ and QuickFlex™ LV CRT leads:

ST. PAUL, Minn.--(BUSINESS WIRE)--Apr. 4, 2012

Commitment to quality

Abbott has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.

We take our responsibilities as a leading manufacturer of cardiac rhythm management devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and function safely and properly.

Product performance

As part of our commitment to quality, we keep medical professionals and their patients informed on the performance of our devices. Abbott releases a semi-annual report detailing overall performance and reliability of its Cardiac Rhythm Management products.

Current and Archived Product Performance Reports.

QuickFlex™ µ and Quartet™ Optim™ insulated leads are not included in this advisory.

QuickFlex™ µ and Quartet™ Optim™ insulated LV CRT leads have demonstrated superior performance during the approximately three years they have been on the market. There have been zero reports of externalized conductors in QuickFlex µ and Quartet Optim LV CRT leads, and they continue to demonstrate excellent performance by any measure.

All QuickFlex µ and Quartet Optim insulated LV CRT leads are constructed with full-body Optim™ insulation, a material shown to be 50 times more abrasion resistant than silicone insulation.¹

Physician Communication: Important Device Upgrade Information – Epic™ & Atlas™ Family of ICDs

January 16, 2008

Dear Doctor,

St. Jude Medical is making a programmer software upgrade available to resolve and eliminate a very rare occurrence (incidence of 8 in 143,000 devices) that could lead to a ventricular sensing anomaly in our Epic™ and Atlas™ families of Implantable Cardioverter Defibrillators (ICDs). The new programmer software (version 6.4.1 for Merlin PCS and version 6.5.1 for Model 3510) will allow a programmer to automatically identify a device that can benefit from a firmware upgrade to resolve and eliminate the potential issue with a simple, one time device software upgrade.

St. Jude Medical Field Sales Staff and Field Clinical Engineers will install this software upgrade in Merlin™ PCS and Model 3510 programmers in the field. Thereafter, upon initial interrogation of an Epic or Atlas family ICD, the Merlin or 3510 programmer will automatically identify implanted devices that require a firmware upgrade and will inform the clinician with a message that an upgrade should be performed. The programmer will complete the device upgrade in approximately 10-20 seconds. During the upgrade process the device continues to function as programmed, with all bradycardia and tachycardia functions fully available.

Approximately 143,000 Epic and Atlas family ICDs have been implanted worldwide since July 2002; approximately 123,000 of these devices remain in service. To date, 8 out of 143,000 of the subject device population (an incidence of 0.00006) have been found to exhibit a loss of ventricular sensing, with a risk of patient harm estimated to be on the order of 1 in 1 million (0.000001).

The loss of ventricular sensing has been attributed to a well defined, yet extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. No patient injuries or deaths have been reported to St. Jude Medical as the result of a device entering the described loss of sensing state. As mentioned above, the potential issue can be fully resolved and eliminated by a programmer initiated upgrade to the device.

In summary:

A simple programmer software/device firmware upgrade will resolve the issue and prevent a future occurrence. Patients who are followed on a routine basis with scheduled follow-up visits every three to six months should continue with their scheduled visit. Upon interrogation of one of the subject devices, the Merlin and Model 3510 programmers with the newly provided software will automatically identify a device that can benefit from a firmware upgrade and will instruct the clinician that an upgrade is available.

St. Jude Medical along with our independent Medical Advisory board members have determined that no other action is recommended.

If you have any questions or would like to discuss this topic in greater detail, please do not hesitate to contact your local Sales Representative or Technical Services at 800-722-3774.

Sincerely,

Kathleen Chester
Vice President, Regulatory Affairs and Quality Assurance

Health care professional notification | Soins de santé notification professionnel

AMPLATZER Septal Occluder (ASO) FDA panel review materials

The FDA occasionally invites medical manufacturers to review device performance in a public forum to determine if any changes are needed for device labeling or whether any additional data needs to be collected to better understand device performance. St. Jude Medical was invited to the Circulatory System Devices Panel of the Medical Devices Advisory Committee for discussion on May 24, 2012.

Supporting materials

Supporting documents for the FDA panel provided by St. Jude Medical include:

The American College of Cardiology (ACC) guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of adult congenital heart disease (ACHD) patients:

The ACC guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of pediatric patients with congenital heart disease;

The AMPLATZER Septal Occluder Delivery System Instructions for Use (IFU) was updated in January 2012:

AMPLATZER Septal Occluder and Delivery System Instructions for Use

Commitment to quality

Abbott has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.

We take our responsibilities as a leading manufacturer of cardiovascular devices very seriously and recognize our primary responsibility as a global medical device manufacturer is to ensure that our devices are of the highest quality and function safely and properly.

For more information, contact Abbott’s Cardiovascular Customer Service at 800-544-1664.

AMPLATZER™ Septal Occluder (ASO) instructions for use updates

This letter is to inform physicians about important information concerning the AMPLATZER Septal Occluder instructions for use.