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

Model Number TF-23A

Device Problems Calcified (1077); Material Perforation (2205)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Event Description

On (b)(6) 2016, a 23mm trifecta valve was implanted in the aortic position.Severe aortic stenosis was confirmed, so on (b)(6) 2019, the device was explanted and observed to be calcified.The device was replaced with a 23mm edwards intuity valve.The patient is reported to be stable.It was noted that the patient had chronic renal insufficiency requiring dialysis.

Event Description

(b)(6) 2016, a 23mm trifecta valve was implanted in the aortic position.Severe aortic stenosis was confirmed, so on (b)(6) 2019, the device was explanted and observed to be calcified, immobile, and a cusp was perforated.The device was replaced with a 23mm edwards intuity valve.The patient is reported to be stable.It was noted that the patient had chronic renal insufficiency requiring dialysis.

Manufacturer Narrative

The valve was explanted due to stenosis.The calcification noted at explant was confirmed.All three leaflets were fibrotically thickened and contained calcifications which immobilized the leaflets and created incomplete coaptation.Fibrous pannus ingrowth was found on the inflow surface of leaflets 1 and 2.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 at the time of commercialization.The root cause of the calcification could not be conclusively determined.Calcification is a known event associated with tissue heart valves.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: 8488201
• MDR Text Key: 141082348
• Report Number: 3008452825-2019-00148
• 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,Followup
• Report Date: 07/16/2019

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: 03/06/2018
• Device Model Number: TF-23A
• Device Lot Number: 5441997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 05/06/2019; 06/17/2019
• Supplement Dates FDA Received: 05/30/2019; 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention