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

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 3008452825-2021-00260, 3014918977-2021-00014.It was reported that there were a total of 3 valve in valves due to structural valve deterioration (svd) noted on trifecta/trifecta¿ gt valves.The physician has doubted the product performance of the models therefore valve in valves were performed.Patient status is unknown.Additional information was request but cannot be obtained.

Manufacturer Narrative

An event of structural valve deterioration and replacement of the valve with a valve-in-valve was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer report number: 3008452825-2021-00260, 3014918977-2021-00014.It was reported that on an unknown date a trifecta gt or a trifecta valve was implanted.On an unknown date a valve in valve was performed due to structural valve degeneration (svd).The physician was not satisfied with the product performance of the valve.Patient status is unknown.Additional information was request but cannot be obtained.

• Brand Name: TRIFECTA GT 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
• MDR Report Key: 12019157
• MDR Text Key: 262723459
• Report Number: 3014918977-2021-00016
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention