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

Catalog Number	TF-19A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
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) 2023, the patient received outpatient treatment for heart failure, and the patient had aortic stenosis symptoms.On (b)(6) 2023, the valve was explanted and replaced with a 23mm epic supra valve.On the explanted valve, calcification was observed around the inflow side, and the left coronary cusp was immobile.The patient was reported to be discharged.The native valve was reported to be 25mm in annulus diameter.There was no history of chronic renal insufficiency, hyperparathyroidism, hypercholesterolemia, diabetes mellitus.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant of the valve due to stenosis was reported.The investigation found that all three leaflets contained calcifications and had fibrous thickening.There was circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter of the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The calcifications and pannus noted on the valve could have contributed to the stenosis reported.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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: 17399257
• Report Number: 2135147-2023-03208
• Device Sequence Number: 14954449
• 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): 08/21/2023

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: 03/28/2018
• Device Catalogue Number: TF-19A
• Device Lot Number: BR00006958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2016
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 54 KG