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

Model Number TF-29A

Device Problems Leak/Splash (1354); Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 06/08/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a 29 mm trifecta valve was implanted.Post-op echocardiogram in (b)(6) 2017 was noted to be fine.On (b)(6) 2017 an echo showed transvalvular regurgitation with failure of one of the leaflets.On (b)(6) 2017, the valve was explanted and a torn leaflet was noted.A 27 mm edwards magna ease valve was implanted.The valve was sent for culture tests, due to the infection concern, and therefore will not be returned.Patient identifier, age, weight and gender is protected under local privacy laws, and therefore is not recorded.

Manufacturer Narrative

An event of transvalvular regurgitation and a torn leaflet was reported.The results of the investigation are inconclusive since the device was not returned for analysis, however four photos were received for analysis.Based solely on the aforementioned photos, one leaflet appeared to have torn away from a stent post.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2017, a 29 mm trifecta valve was implanted.Post-op echocardiogram in (b)(6) 2017 was noted to be fine.On (b)(6) 2017 an echo showed transvalvular regurgitation with evidence of a leaflet failure.On (b)(6) 2017, the valve was explanted and a torn leaflet was noted.A 27 mm edwards magna ease valve was implanted.The valve was sent for culture tests, due to the infection concern, and therefore will not be returned.A copy of the explant and path report were not made.The patient is doing well with no further issues.Patient identifier, age, weight and gender is protected under local privacy laws, and therefore is not recorded.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7157565
• MDR Text Key: 96157891
• Report Number: 3008452825-2018-00002
• Device Sequence Number: 1
• Product Code: LWR
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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: No Information
• Device Expiration Date: 09/21/2017
• Device Model Number: TF-29A
• Device Catalogue Number: TF-29A
• Device Lot Number: 5270575
• Other Device ID Number: 05414734052061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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): Hospitalization; Required Intervention