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

Catalog Number	TF-25A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/30/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
User facility medwatch report #mw5144860 received that states "my husband, "(b)(6)," born on (b)(6) 1942 received a valve replacement on (b)(6) 2018.It failed and deteriorated and he died on (b)(6) 2023.Abbott trifecta tissue heart valve; "st jude medical center".Serial no: (b)(6), model t5-25a; 1-800-344-5833.It don't have access to medical records.My husband was admitted to (b)(6) medical center on (b)(6) 2023 and died on (b)(6) 2023.Hospital address and phone: (b)(6), phone (b)(6).There were multiple tests." it was reported that on (b)(6) 2018, a 25mm trifecta valve was implanted during an aortic valve replacement.It was later reported on (b)(6) 2023, the patient presented to the hospital with dyspnea and congestive heart failure due to prosthetic valve stenosis.Prosthetic valve stenosis was confirmed in echocardiography with high gradient, mean gradient of 56 mmhg, and a velocity of greater than 4.6 m/sec.It was reported the patient passed away on (b)(6) 2023 due to acute on chronic congestive heart failure.
Additional Manufacturer Narrative
An event of dyspnea and congestive heart failure due to prosthetic valve stenosis after more than four years of implant and patient death was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.However, based on the information received, the reported stenosis is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors which can result in stenosis also could not be confirmed as the valve was not returned for histopathological examination.It is unknown whether the patient underwent any additional intervention such as a repeat surgical aortic valve replacement of a transcatheter valve-in-valve intervention to address the svd.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident 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: 17809994
• Report Number: 2135147-2023-04163
• Device Sequence Number: 15249721
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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: 09/15/2019
• Device Catalogue Number: TF-25A
• Device Lot Number: 5738892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Male