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

Model Number TF-21A

Device Problem Leak/Splash (1354)

Patient Problems Aortic Insufficiency (1715); Pulmonary Edema (2020)

Event Date 11/17/2017

Event Type  Injury  

Event Description

On (b)(6) 2012, a 21mm sjm trifecta valve was implanted.On (b)(6) 2017, the patient presented at the hospital with pulmonary edema and aortic insufficiency most likely due to prolapse of one of the trifecta valve leaflets.On (b)(6) 2017, the trifecta valve was explanted and replaced with a 23mm perceval sutureless valve, s-m23.

Manufacturer Narrative

An event of explant due to aortic insufficiency and pulmonary edema was reported.Morphological and histopathological examination revealed all three leaflets were torn at their base and circumferential fibrous pannus ingrowth had encroached onto the inflow surfaces of leaflets 1 and 2.Stent post 3 had been bent outwards.No inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, aortic insufficiency is consistent with torn leaflets.

• 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 ; 6517565400
• MDR Report Key: 7317540
• MDR Text Key: 101631301
• Report Number: 3008452825-2018-00063
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2013
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3550525
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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; Required Intervention
• Patient Age: 81 YR