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

Catalog Number	TF-19A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that on (b)(6) 2016, a 19mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2016, a transvalvular leak was found at center position.On (b)(6) 2021, the patient presented to the facility and was diagnosed with aortic stenosis.A light to moderate transvalvular leak was noted at the center position.On (b)(6) 2022, a moderate transvalvular leak was noted at the center position, and aortic stenosis was observed.On (b)(6) 2023, a transvalvular leak was recognized at the center position, and aortic stenosis was observed.Moderate aortic regurgitation and valvular insufficiency were noted.Structural valve deterioriation (svd) was suspected.From (b)(6) 2023 to (b)(6) 2023, the patient was admitted for heart failure.On (b)(6) 2023, the 19mm trifecta valve was explanted.The n side of the left coronary cusp (lcc) and the right side of the non-coronary cusp (ncc) were completely disconnected.A ring-shaped pannus had formed under the valve.A 19mm non-abbott valve was implanted as a replacement.The patient status was unknown.
Additional Manufacturer Narrative
An event of transvalvular leak, aortic stenosis, moderate aortic regurgitation, valvular insufficiency and heart failure was reported.The valve was explanted as structural valve deterioration was suspected and it was found that the left coronary cusp (lcc) and the right side of the non-coronary cusp (ncc) were completely disconnected.A more comprehensive assessment, including histopathological examination of the valve tissue 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 specifications.Based on the information received, the event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17414449
• Report Number: 2135147-2023-03302
• Device Sequence Number: 6983261
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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): 08/11/2023

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: 08/20/2017
• Device Catalogue Number: TF-19A
• Device Lot Number: 5223497
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2015
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 44 KG