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

Device Problem Insufficient Information (3190)

Patient Problem Heart Failure (2206)

Event Type  malfunction  

Manufacturer Narrative

An event of "trifecta valve failure" requiring valve-in-valve was reported.A more comprehensive assessment could not be performed 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

On an unknown date, about 3-4 years ago, a trifecta valve , size unknown was successfully implanted in the patient.The patient presented to the hospital with heart failure due to trifecta valve failure and the patient was required to undergo a valve in valve procedure.The valve in valve procedure was done in the week of (b)(6) 2020 and a non-abbott valve was implanted.The current patient status is unknown.

• 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 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: 10505659
• MDR Text Key: 206165918
• Report Number: 3008452825-2020-00438
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/08/2020

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: 08/12/2020
• Initial Date FDA Received: 09/08/2020
• 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