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

Model Number TF-23A

Device Problem Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Type  Injury  

Event Description

On an unknown date, a 23mm trifecta valve was implanted.In (b)(6) 2018, the valve was explanted due to severe symptomatic bioprosthetic aortic insufficiency from spontaneous avulsion of the right and non coronary cusps of the bioprosthetic valve.The patient is reported to be recovering.

Manufacturer Narrative

An event of aortic insufficiency due to torn leaflets was reported.The torn leaflets were confirmed.Morphological and histopathological examination revealed all three leaflets were torn.The valve contained circumferential fibrous pannus ingrowth on its inflow 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 root cause of the tears and pannus remains unknown; however, information from the field indicated the valve had been implanted for more than six years.

Event Description

On (b)(6) 2012, a 23mm trifecta valve was implanted.A pre-operative echo showed severe symptomatic bioprosthetic aortic insufficiency from spontaneous avulsion of the right and non coronary cusps of the bioprosthetic valve.On (b)(6) 2018, the valve was explanted.A 25mm carpentier-edwards perimount valve was implanted as the replacement.On (b)(6) 2018, the patient was discharged from the hospital.

• 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: 7573952
• MDR Text Key: 110239053
• Report Number: 3008452825-2018-00171
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

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: 08/29/2013
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3602911
• Other Device ID Number: 05414734052030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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; Required Intervention
• Patient Age: 69 YR