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

Catalog Number	TF-19A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, a 19mm trifecta valve was implanted in an aortic valve replacement.The native valve dimension was 22mm.In (b)(6) 2022, progression of aortic stenosis became apparent with a valve pressure gradient of 40mmhg.In (b)(6) 2023, the patient had a valve pressure gradient of 40mmhg and worsening dyspnea, and the patient was urgently hospitalized due to signs of heart failure.On (b)(6) 2023, the 19mm trifecta valve was explanted.Visualization of the explanted valve exhibited pannus, calcification, and thrombus.Thrombus could not be confirmed via echocardiogram previously.A replacement 21mm epic supra valve was implanted.The patient was reported to be stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to aortic stenosis, worsening dyspnea and signs of heart failure was reported.Also reported was visualization of the explanted valve exhibited pannus, calcification, and thrombus.The investigation found calcifications on all three leaflets with immobilization/limited mobility of all leaflets.There was fibrous pannus ingrowth on outflow surface of leaflets 1 and 2.Thin layer of fibrin present on inflow surface of leaflets 1 and 2.Leaflet 3 was torn.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear in leaflet could not be conclusively determined; however, was associated with calcifications.The calcifications found would have contributed to the reported stenosis.

• 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: 18322141
• Report Number: 2135147-2023-05481
• Device Sequence Number: 7459819
• 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: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 12/04/2015
• Device Catalogue Number: TF-19A
• Device Lot Number: 4555309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2013
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 45 KG