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

Model Number TF-25A

Device Problems Microbial Contamination of Device (2303); Torn Material (3024)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Event Description

On (b)(6) 2015, a 25mm trifecta was implanted.In 2018, at an unknown point in time, it is reported the patient underwent redo avr due to a tear along the stent which the user reported was most likely caused by endocarditis with streptococci.The procedure was completed with a non-abbott 25mm magna ease valve.The trifecta valve was sent to hospital bacteriology department for analysis which was inconclusive as the patient had been treated with antibiotics.Additional records were not available.

Manufacturer Narrative

Events of severe aortic leakage and a torn leaflet were reported.The results of the investigation are inconclusive since the device was not returned for analysis, however two photos were received for analysis.Based solely on the aforementioned photos, two leaflets appeared to have torn away from a stent post.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; 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7660749
• MDR Text Key: 113152539
• Report Number: 3008452825-2018-00206
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2018
• 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): Hospitalization; Required Intervention