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

Model Number TF-25A

Device Problems Torn Material (3024); Insufficient Information (3190)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/09/2017

Event Type  Injury  

Event Description

On (b)(6) 2016, an aortic valve replacement (avr) was performed and this 25mm trifecta valve was implanted.On (b)(6) 2017, the patient complained of chest pain on exertion and was seen in the outpatient clinic where an echocardiogram revealed aortic regurgitation (ar).Following the initial assessment, the patient's symptoms worsened and a repeated echocardiogram was performed which showed increased ar.On (b)(6) 2017, re-do avr was performed and this valve was explanted.At explant, of this valve, one of the cusps was observed to be torn.A 23mm carpentier-edwards perimount magna aortic heart valve was implanted as a replacement valve.The surgeon commented that as the patient has no medical history of infective endocarditis (ie) or dialysis or diabetes and the leaflet tear observed was early structural valve deterioration (svd).Patient specific information is not available for this complaint and an update on the patient's postoperative condition has been requested.

Manufacturer Narrative

The reported event of a torn leaflet was confirmed.Gross morphological and histopathological examination revealed tears on the base of all three leaflets, and fibrous pannus ingrowth on the base of leaflet 2.No acute 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.

• 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 (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7099572
• MDR Text Key: 94232974
• Report Number: 3008452825-2017-00314
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2018
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 5481181
• Other Device ID Number: 05414734052047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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): Required Intervention
• Patient Age: 67 YR