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

Catalog Number	TF-23A
Medical Device Problem Codes	Perivalvular Leak (1457); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of structural valve deterioration, perivalvular leak, central regurgitation, device stenosis, fatigue, aortic valve stenosis, aortic valve regurgitation, and dyspnea was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Reportedly, the patient returned with structural valve deterioration of the trifecta valve and had dyspnea and fatigue along with aortic stenosis, perivalvular leak, and aortic regurgitation.Then, it was decided to implant a navitor valve in valve to treat the issue.At 80% deployment, the valve was at 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 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.Then, a second navitor valvewas implanted at 5mm.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 iiiwas implanted which reduced the pvl to trace.Based on the available information, the root cause of the reported incidents could not be conclusively determined.There is no indication of a product issue with regards to manufacture, design, or labeling.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: 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
• Report Number: 2135147-2024-01601
• Device Sequence Number: 6271792
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)161207(10)BR00000823
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female