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

Model Number TF-23A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results / method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2012, a 23 mm trifecta valve was implanted.On (b)(6) 2019, the valve was explanted due to non degenerated valvular cusp.It was noted that the right coronary cusp was detached on the sewing cuff side.The valve was exchanged for another 23 mm trifecta valve.The patient status is unknown.

Manufacturer Narrative

Explant was reported due to insufficiency.The investigation found that leaflets 1 and 3 were torn.There was fibrous pannus ingrowth on the inflow surface of leaflets 1 and 3.There was no inflammation or significant calcifications present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site, and the cause of the leaflet tear could not be conclusively determined.

• 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
• MDR Report Key: 9219761
• MDR Text Key: 163197382
• Report Number: 3008452825-2019-00523
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2013
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3622400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR