MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-23A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Heart Failure (2206); Stenosis (2263)

Event Date 09/07/2015

Event Type  Death  

Manufacturer Narrative

An event of low gradient, stenosis, heart failure, and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the site "a valve in valve procedure was planned to treat the issue; however, the patient was reported to be too frail to undergo the procedure".

Event Description

On (b)(6) 2015, a 23 mm trifecta valve was implanted.On (b)(6) 2018, a low gradient was observed and the patient was reported to have severe stenosis and heart failure.A valve in valve procedure was planned to treat the issue; however, the patient was reported to be too frail to undergo the procedure.The patient was reported to have expired on an unknown date.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8767334
• MDR Text Key: 150260904
• Report Number: 3008452825-2019-00317
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

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 Expiration Date: 03/17/2017
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 5045388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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): Death; Required Intervention