MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Calcified (1077); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Insufficiency, Valvular (1926); Cardiac Tamponade (2226); Post Operative Wound Infection (2446); Valvular Stenosis (2697); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 181 trifecta valves out of 2,584 implanted were explanted for early failure due to either calcification or leaflet tears.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying a trifecta valves that may be related to explants.2,548 patients with a mean age of 69 years at implantation were part of the study.Details are listed in a poster presented in a conference "early structural valve deterioration of the trifecta valve: a propensity matched comparison of 2,052 implants." from october 2007 to september 2018, 2,584 patients at a single center underwent aortic valve replacement with a trifecta valve.It was noted in that the trifecta valve exhibits a more rapid increase in transvalvar gradients and more valvular insufficienty.The freedom from explant at 5 years was 93% for the trifecta valve, resulting in 7% (181 valves of the 2,584 valves implanted) of the valves explanted.Primary failure mode for trifecta was leaflet calcification resulting in stenosis, while a minority of the explants were due to leaflet tears.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10 as reported in a research article, complications from having a trifecta valve implanted included stroke, atrial fibrillation, ventilation, bleeding, renal failure, septicemia, wound infection, replacement of the valve, regurgitation, and stenosis.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Subsequent to the initially filed information, the following information was received on 03 may 2021: the article, "durability and performance of 2298 trifecta aortic valve prostheses: a propensity-matched analysis: a single centre experience", was reviewed.This research article is a retrospective single center experience to evaluate hospital outcomes, hemodynamic performance, and valve explant of the trifecta valve compared with the perimount valve (edwards lifesciences).Trifecta valve, trifecta gt valve, perimount valve were associated with the study.There were allegations of malfunction of the trifecta and trifecta gt valves.The article concluded compared with the extensively studied perimount valve, the trifecta valve exhibits a more rapid increase in transvalvular gradients, more regurgitation, and lower freedom from explant at 5 years.The primary author of the article is (b)(6), the correspondence author is (b)(6) with the corresponding email: (b)(6)].Related manufacturing reference number 3014918977-2021-00006.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 9654969
• MDR Text Key: 177984107
• Report Number: 3008452825-2020-00067
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 69 YR