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 11/01/2017

Event Type  Injury  

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed and a 21mm trifecta stented tissue valve (tf) was implanted.On (b)(6) 2017, a redo avr was performed because of severe aortic regurgitation and the tf was explanted.Upon explant of the valve a right coronary cusp was observed to be torn at the bottom of the cusp.A carpentier-edwards perimount magna ease aortic heart valve (size unknown) was implanted.Patient specific information of patient identifier, birthdate, and weight are not available for this complaint.

Manufacturer Narrative

Product investigation: the reported event of a torn leaflet was confirmed.Gross morphological and histopathological examination found leaflets 2 and 3 to be torn.No acute inflammation or significant calcifications were present in the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed and a 21mm trifecta stented tissue valve (tf) was implanted.From ecg (lvdd): 60mm,(lvds)40mm, aod:28mm, ef:71%, mr:moderate, tr: moderate, peak pressure gradient (ppg)=56mmhg, pulmonary artery pressure (pap)=71mmhg.On (b)(6) 2017, a redo avr was performed because of severe aortic regurgitation and the tf was explanted.Upon explant of the valve a right coronary cusp was observed to be torn at the bottom of the cusp.A carpentier-edwards perimount magna ease aortic heart valve (size unknown) was implanted.

Event Description

On (b)(6) 2013, an aortic valve replacement (avr) was performed and a 21mm trifecta stented tissue valve (tf) was implanted.From ecg (lvdd): 60mm,(lvds) 40mm, aod:28mm, ef:71%, mr:moderate, tr: moderate, peak pressure gradient (ppg)=56mmhg, pulmonary artery pressure (pap)=71mmhg.On (b)(6) 2017, a redo avr was performed because of severe aortic regurgitation and the tf was explanted.Upon explant of the valve a right coronary cusp was observed to be torn at the bottom of the cusp.A carpentier-edwards perimount magna ease aortic heart valve (size unknown) was implanted.Patient specific information of patient birthdate, and weight are not available for this complaint.

• 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: 7053762
• MDR Text Key: 92786651
• Report Number: 3008452825-2017-00290
• 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,Followup,Followup
• Report Date: 01/16/2018

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: 10/28/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4036511
• Other Device ID Number: 05414734052023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 12/20/2017
• Supplement Dates FDA Received: 12/21/2017; 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2012
• 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: 72 YR
• Patient Weight: 60