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

Model Number TF-27A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

In 2013, a 27mm trifecta valve was implanted.On (b)(6) 2019, a valve in valve procedure was performed.The patient is alive and recovering as expected.

Manufacturer Narrative

An event of a valve-in-valve performed on a trifecta for an unknown reason was reported.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA 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: 9511696
• MDR Text Key: 172599079
• Report Number: 3008452825-2019-00658
• 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
• Report Date: 01/14/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention