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

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that in 2018, a tissue heart valve was implanted.On (b)(6) 2021, the valve had failed and was explanted.The device was replaced with a competitor valve to resolve the event.The patient remained hemodynamically stable throughout the procedure, is stable and doing well.No additional information was provided.

Manufacturer Narrative

Additional information: d1, d3, g1.

Manufacturer Narrative

Explant was reported due to the valve having "failed".The investigation found that there was circumferential fibrous pannus ingrowth on the inflow and outflow surfaces of the valve which limited the leaflet mobility and narrowed the inflow diameter.No acute inflammation or significant calcifications were present.While the exact reason for valve explant remains unknown, the pannus ingrowth impeding leaflet mobility and narrowing the inflow diameter could lead to a number of potential issues with valve functionality.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12155463
• MDR Text Key: 264388981
• Report Number: 3001883144-2021-00107
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 10/28/2021
• Supplement Dates FDA Received: 08/31/2021; 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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