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

Catalog Number	TF-25A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	10/12/2023
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 informationna.
Event or Problem Description
It was reported that in 2016, a 25mm trifecta valve was implanted during an aortic valve replacement.Later on an unknown date, the patient had high gradient and follow up imaging with echocardiography was performed.Stenosis and calcification were noted.On (b)(6) 2023, a 25mm navitor valve was implanted into the trifecta valve, in an off-label valve-in-valve procedure.The patient remained hemodynamically stable during the procedure.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of stenosis and calcification was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as a valve-in-valve was performed and the device remains implanted.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.A variety of factors may contribute to svd, including patient, biological, and implant related factors: 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 such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination, although in this case calcification was reported to be present on the valve.Information from the field indicated that patient had renal insufficiency, which could contribute to calcification formation.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 #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: 18075018
• Report Number: 2135147-2023-04883
• Device Sequence Number: 7684423
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/18/2024

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 Catalogue Number: TF-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown