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

Model Number TF-23A

Device Problems Calcified (1077); Material Erosion (1214)

Patient Problem Aortic Insufficiency (1715)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Degeneration of a trifecta 5tf-23a, that had been implanted in (b)(6) 2015 was determined.The valve was explanted and replaced on (b)(6) 2020 with a 21 mm regent valve.Upon explant calcification at the top of the stent pins was present and confirmed.The patient remained stabled throughout the procedure and no patient consequences were reported.

Manufacturer Narrative

The reported calcification was confirmed.All leaflets contained calcifications and associated tears.All leaflets were fibrotically thickened.Fibrous pannus ingrowth was noted on the outflow surface covering stent posts 1 and 2 and encroaching onto leaflets 1 and 2, and on the inflow surface of leaflet 2.The leaflet mobility was limited due to the calcifications and pannus.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the calcifications and associated leaflet tears are consistent with the reported degeneration, the host to device reaction (pannus formation), along with the selected valve size (23 mm) larger than the replacement valve (21 mm), are possible evidence of interaction with patient anatomy.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 11066267
• MDR Text Key: 223431455
• Report Number: 3008452825-2020-00704
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2017
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4998893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR