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

Model Number TF-23A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

An event of transvalvular regurgitation, shortness of breath, fatigue, and episodes of chest pain was reported.The results of the investigation are inconclusive since 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

The 23mm trifecta valve was implanted on (b)(6) 2017.On (b)(6) 2019 severe transvalvular aortic regurgitation was noted.The patient noted that over the previous 3 months they had been experiencing shortness of breath, fatigue, and episodes of chest pain.Scans revealed a non-calcific leaflet tear in the trifecta valve.The patient reported that they had ceased taking statin and exchanged their aspirin for asasantin against the physicians advice.The patient's medication was adjusted.It was reported that the site planned to explant and replace the valve.Additional information has been requested.

• Brand Name: SJM TRIFECTA 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 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9178824
• MDR Text Key: 161939575
• Report Number: 3008452825-2019-00476
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2019
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: BR00012675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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): Hospitalization; Required Intervention