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

Catalog Number	TF-19A
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "transcatheter heart valve stuck in a surgical bioprosthesis during valve-in-valve transcatheter aortic valve replacement", was reviewed.The article presented a case study of a 77-year-old man.It was reported that on an unknown date, a 19mm trifecta valve was implanted.It was later reported on an unknown date, the patient presented with severe transvalvular aortic regurgitation (ar) due to structural valve degeneration of the 19mm trifecta valve.A decision was made to perform a valve-in-valve (viv) procedure with a 23mm evolut pro+ (medtronic).Pre-procedural multidetector computed tomography (mdct) noted the trifecta valve had been obliquely implanted.During procedure, the stent post of the trifecta valve had protruded into the evolut pro+ strut and became deformed when attempting to resheath the evolut pro+.The evolut pro+ system was forcefully withdrawn from the trifecta which resulted in serious leaflet damage to the trifecta and extracorporeal membrane oxygenation (ecmo) for torrential ar.The evolut pro+ valve was successfully implanted during the second attempt and hemodynamics were stabilized.The article concluded attention should be paid to the risk of this phenomenon during the viv-transcatheter aortic valve replacement (tavr), especially when they are not coaxial.[the primary author was masanori kawaguchi, cardiovascular department, suwa red cross hospital, 5-11-50 kogandori, suwa, 392-8510 nagano, japan.The corresponding author was fumiaki yashima, department of cardiology, saiseikai utsunomiya hospital, 911-1 takebayashi-cho, utsunomiya, 321-0974 tochigi, japan, with corresponding email: yashima.Fumiaki@gmail.Com].
Additional Manufacturer Narrative
Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including unknown comorbidities.Some of the complications reported were severe transvalvular aortic regurgitation, surgical intervention for valve in valve, stent post deformation, serious leaflet damage and hospitalization.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 18148976
• Report Number: 2135147-2023-05051
• Device Sequence Number: 17896540
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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 Catalogue Number: TF-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/16/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male