Trifecta™ GT

Important Safety Information

INDICATION FOR USE

The Trifecta™ Valve with Glide™ Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

CONTRAINDICATIONS

None known.

WARNINGS

• For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
• Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 Trifecta Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
• Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
• Accelerated deterioration of the valve may occur in:
  • Children, adolescents, or young adults
  • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
  • Individuals requiring hemodialysis
• Do not use if:
  • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
  • The expiration date has elapsed.
  • The tamper-evident jar seal is damaged, broken, or missing or if fluid is leaking from the packaging.
  • The storage solution does not completely cover the valve.
• Use only the Trifecta™ Model TF2000 sizers¹ for sizing the valve.
• The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

PRECAUTIONS

• Safety and effectiveness of the valve has not been established for the following specific populations:
  • Patients who are pregnant
  • Nursing mothers
  • Patients with chronic renal failure
  • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
  • Patients with chronic endocarditis
  • Patients requiring pulmonic or tricuspid valve replacement
  • Children, adolescents, or young adults
• Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
• Do not place the non-sterile exterior of the valve jar in the sterile field.
• Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
• Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped,  the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline  used to irrigate the valve.
• Do not add antibiotics to either the valve storage solution or the rinse solution.
• Do not apply antibiotics to the valve.
• Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
• Do not implant the valve without thoroughly rinsing as directed.
• Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
• Never handle the leaflet tissue.
• Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact,  thoroughly flush any skin exposed to the solution with water. In case of contact with eyes flush with water and seek appropriate medical care.
• Use caution when placing sutures through the  sewing cuff to avoid lacerating the valve tissue.  If a valve is damaged, the valve must be replaced.
• Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
• Do not attempt to repair a valve. Damaged valves must not be used.
• Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
• Use caution when tying knots to avoid bending  the stent posts.

ADVERSE EVENTS

The Trifecta™ Valve with Glide™ Technology is based upon the Trifecta™ Valve design. Therefore, a previous clinical investigation of the Trifecta™ Valve supports the safety of the Trifecta™ Valve with Glide™ Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

Adverse events potentially associated with the use of bioprosthetic heart valves include:

• angina
• cardiac arrhythmias
• endocarditis
• heart failure
• hemolysis
• hemolytic anemia 
• hemorrhage
• leak, transvalvular or paravalvular
• myocardial infarction
• nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
• prosthesis regurgitation
• stroke
• structural deterioration (calcification, leaflet tear, or other)
• thromboembolism
• valve thrombosis

It is possible that these complications could lead to:

• reoperation
• explantation
• permanent disability
• death

See the Clinical Study section of these instructions for adverse event data collected in the Trifecta™ Valve clinical investigation.

1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.