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

Catalog Number TF-23A

Device Problems Perivalvular Leak (1457); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that on a (b)(6) 2015 a 23mm trifecta aortic valve was implanted successfully.On (b)(6) 2023, the patient returned with structural valve deterioration of the 23mm trifecta valve.The patient had dyspnea and fatigue along with aortic stenosis, perivalvular leak, and aortic regurgitation.On (b)(6) 2024, it was decided to implant a 25mm navitor valve in valve to treat the issue.Measurements not obtained via computerized tomography (ct) for the procedure.The 25mm navitor was advanced through the trifecta utilizing a small flexnav delivery system (lot: 9048461).At 80% deployment, the valve was at an acceptable height in related to the base of the trifecta, but a small perivalvular leak (pvl) was present.The valve was fully deployed at 5-6mm below the base of the trifecta and post dilatation was performed with a 22mm non-abbott balloon valvuloplasty (bav).Following post dilatation, the valve migrated into the left ventricular outflow tract (lvot) at a depth of 10mm and moderate pvl remained.The patient however remained hemodynamically stable.No repositioning of the migrated valve was attempted.A second 25mm navitor valve (serial: (b)(6)) was implanted at 5mm (base of trifecta) using a replacement small flexnav delivery system (lot: 9048461).Post bav was performed with 24mm balloon.The implantation of the second valve improved the pvl to mild.The mild leak was observed to still be coming from the first 25mm navitor.A amplatzer valvular plug iii (lot: 7710116) was implanted which reduced the pvl to trace.The procedure was then completed and patient was transferred to recovery.The patient was reported to be stable.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.

Manufacturer Narrative

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

• 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 (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19067935
• MDR Text Key: 339675725
• Report Number: 2135147-2024-01601
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)161207(10)BR00000823
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 04/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2016
• Device Catalogue Number: TF-23A
• Device Lot Number: BR00000823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female