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

Model Number TF-21A

Device Problem Incomplete Coaptation (2507)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/23/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022: additional information was reviewed.Procedure description was updated.No changes were made to reportability assessments.All significant available information has been received.No additional requests for information are needed., a 21mm trifecta valve was implanted.The implanting physician reported that there were no procedural complications, and an echocardiogram performed post-procedure confirmed that the device was working as intended.The patient later returned to the hospital for a check up.During a transesophageal echocardiogram (tee), it was revealed that one of the valve cusps was stuck in an open position, causing severe regurgitation.On (b)(6) 2022, the device was explanted and replaced with a non-abbott valve.The patient was later discharged.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Please reference previous manufacturer report number 3005334138-2022-00174.Explant due to valves leaflet being stuck in an open position causing sever regurgitation was reported.One leaflet appeared pinched and was visibly underperforming during functional testing upon return of the valve to abbott.Functional testing at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet 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, including inspection for proper leaflet coaptation.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.The cause of the reported event could not be conclusively determined, however it is possible the valve structure was damaged during implant or explant of the valve, which could have impacted the coaptation of the leaflets.

Event Description

It was reported that on (b)(6) 2022, a 21mm trifecta valve was implanted.The implanting physician reported that there were no procedural complications, and an echocardiogram performed post-procedure confirmed that the device was working as intended.The patient later returned to the hospital for a check up.During a transesophageal echocardiogram (tee), it was revealed that one of the valve cusps was stuck in an open position, causing severe regurgitation.On (b)(6) 2022, the device was explanted and replaced with a non-abbott valve.The patient was later discharged.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16438576
• MDR Text Key: 310227819
• Report Number: 2135147-2023-00665
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00015668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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): Required Intervention; Hospitalization
• Patient Sex: Female