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

Model Number TF-21A

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Product investigation: the an event of valve explant due to leakage was reported, and the observed tear was confirmed.Morphological and histopathological examination found leaflets 2 and 3 were torn and leaflet 1 contained focal fibrous pannus ingrowth on its outflow surface.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported tear remains unknown; however, leakage is consistent with torn leaflets.

Event Description

On (b)(6) 2015, an aortic valve replacement (avr) was performed and this 21mm trifecta valve was implanted.On (b)(6) 2017, leakage of this valve was observed.On (b)(6) 2018 the trifecta valve was explanted and a 21mm cep magna ease aortic heart valve was implanted.The physician commented that there was an approximately 1cm leaflet tear observed near one stent post of the explanted trifecta.Neither pannus nor calcification was noted on the valve.The patient has been in stable condition postoperatively.

• 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: 7280598
• MDR Text Key: 100394946
• Report Number: 3008452825-2018-00020
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/19/2018

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: Health Professional
• Device Expiration Date: 04/18/2017
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 5079548
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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; Other
• Patient Age: 75 YR