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

Model Number TF-23A

Device Problems Difficult or Delayed Positioning (1157); Perivalvular Leak (1457)

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

Event Date 06/19/2019

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) 2019, a 23mm trifecta valve was selected for implant.During the procedure, the physician reported difficulty parachuting the valve into the native annulus.The valve was successfully implanted; however, severe paravalvular leakage was confirmed after the patient was removed from bypass.The physician elected to explant the valve and implant a 23mm resilia inspiris valve.No patient consequences were reported.Per the site, the reported valve was implanted by non-everting mattress suturing technique and the physician stated the suture technique may have been related to pvl.

Manufacturer Narrative

The reported event of paravalvular leakage could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.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 cause of the reported event could not be conclusively determined; however, per the site the suture technique may have been related to the leakage.

Event Description

On (b)(6) 2019, a 23mm trifecta valve was selected for implant.During the procedure, the physician reported difficulty parachuting the valve into the native annulus.The valve was successfully implanted; however, severe paravalvular leakage was confirmed after the patient was removed from bypass.The physician elected to explant the valve and implant a 23mm resilia inspiris valve.No patient consequences were reported.

• 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: 8796179
• MDR Text Key: 151263399
• Report Number: 3008452825-2019-00345
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2020
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 6593961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention