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

Catalog Number	TF-23A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/01/2023
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.Literature attachment: article title "early structural valve deterioration of trifecta aortic bioprosthesis : report of a case".
Event or Problem Description
The article, "early structural valve deterioration of trifecta aortic bioprosthesis : report of a case", was reviewed.The article presented a case study of a 60-year-old male patient who underwent aortic valve replacement.It was reported that on an unknown date, a 23mm trifecta valve was implanted.Seven years post-procedure on an unknown date, the patient presented with progressive dyspnea, severe aortic regurgitation, and aortic stenosis.It was noted intraoperatively there was a large laceration in the left coronary cusp adjacent to the non-coronary and left coronary commissure and leaflet calcification.Further investigation noted circumferential fibrous pannus ingrowth at the inflow portion.A decision was made to explant the trifecta valve and replaced with an inspiris valve of unknown size.The patient additionally underwent concomitant mitral valve plasty and left atrial appendage clipping.The patient was reported stable and transferred to a rehabilitation facility on the 36th postoperative day.[the primary author was keita tanaka, japanese red cross medical center, tokyo, japan.].
Additional Manufacturer Narrative
Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with unknown co-morbidities.Some of the complications reported were surgical intervention, hospitalization, dyspnea, aortic valve regurgitation, aortic valve stenosis, torn cusp, calcified device and pannus.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: 18405967
• Report Number: 2135147-2023-05733
• Device Sequence Number: 2690945
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/10/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 53 KG