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

Model Number	TF-A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	06/13/2023
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.
Event or Problem Description
It was reported on (b)(6) 2013, a 23mm trifecta valve was implanted in a patient.It was later reported on (b)(6) 2023, the patient presented with dyspnea on exertion.An echocardiography confirmed increased pressure gradient due to aortic stenosis.A decision was made to explant the 23mm trifecta valve.The valve was replaced with a 23mm non-abbott valve that was successfully implanted in the patient.It was observed there was calcification on the explanted valve.
Additional Manufacturer Narrative
Explant of the valve due to increased pressure gradient caused by aortic stenosis, with calcification being noted on the explanted valve was reported.The investigation found that all three leaflets contained calcifications which limited the mobility of the leaflets.Leaflet 3 was torn which was associated with a calcification.All three leaflets contained fibrous thickening.There was circumferential pannus ingrowth on the inflow surface of the valve and on the outflow surface if leaflets 2 and 3.No 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 calcifications limiting the mobility of the valve leaflets could have contributed to the reported stenosis.There is no indication of a product quality 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: 17282809
• Report Number: 2135147-2023-02935
• Device Sequence Number: 19703115
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• 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: 2013
• 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): 08/17/2023

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: 04/25/2014
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3810915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2012
• 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: 73 YR
• Patient Sex: Male