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

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/15/2018

Event Type  Injury  

Event Description

A trifecta¿ gt valve was explanted on (b)(6) 2018 due to severe aortic regurgitation.After the device was removed, two leaflets were seen torn from the stent structure per report.Initial valve implant was (b)(6) 2014 at a non-reporting facility.

Manufacturer Narrative

The valve was explanted due to aortic regurgitation.The two reported leaflet tears were confirmed.Gross morphological and histopathological examination revealed that leaflets 1 and 3 contained tears and circumferential fibrous pannus ingrowth encroached onto the bases of all three leaflets and narrowed the inflow diameter.No acute inflammation or significant calcifications were found.Aortic regurgitation is consistent with torn leaflets; however the cause of the tears remains unknown.

Event Description

On (b)(6) 2014 a patient received a unknown size of trifecta valve.On (b)(6) 2018 the valve was explanted due to severe aortic regurgitation.After explant, two leaflets were noted to be torn from the stent post.The explant was performed at the non-implanting center.

• Brand Name: TRIFECTA¿ GT 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: 7277438
• MDR Text Key: 100303749
• Report Number: 3008452825-2018-00018
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P100029/S021
• 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,Followup
• Report Date: 07/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 03/05/2018
• Supplement Dates FDA Received: 03/30/2018; 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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; Other
• Patient Age: 67 YR