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

Model Number TFGT-23A

Device Problems Backflow (1064); Gradient Increase (1270); Obstruction of Flow (2423); Improper Flow or Infusion (2954); Material Split, Cut or Torn (4008)

Patient Problems Aortic Insufficiency (1715); Congestive Heart Failure (1783)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a trifecta gt valve was explanted due to insufficiency caused by a leaflet tear.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article "early failure of the trifecta gt bioprostheses" was reviewed.This research article is a case study on a (b)(6)-year-old female that was implanted with a 23mm trifecta gt valve in 2016.The valve was implanted using pledget.At 1.4 years follow up, the patient had a mean gradient of 7 mmhg and no aortic insufficiency (ai).On an unknown date in 2019, the patient presented symptoms of heart failure.The patient had a mean gradient of 16mmhg and ai was observed.The trifecta valve was explanted and replaced with an unknown valve.It was observed that the cusp was detached at the stent post between the noncoronary and the right coronary cusps.The patient had unremarkable postoperative course.There is allegation of malfunction of the abbott device.The primary author of the article is lise tchouta, md, msc,, department of cardiac surgery, university of michigan health systems, ann arbor, michigan.The corresponding author is shinichi fukuhara, md of department of cardiac surgery, university of michigan, with the email: fukuhara@med.Umich.Edu.

• Brand Name: TRIFECTA GT 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 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10538331
• MDR Text Key: 207121394
• Report Number: 3008452825-2020-00482
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFGT-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR