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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Summarized patient outcomes/complications of transcatheter replacement of a tissue valve, including trifecta valves were reported in a research article.Aortic regurgitation was reported as one of the pre-existing conditions prior to replacement of the valves.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, ¿predicted vs observed valve to coronary distance in valve-in-valve tavr¿, was reviewed.The article presented a retrospective, single-center study to investigate the agreement of predicted valve-to-coronary ostia (vtc) and valve-to-sinus (vts) distances and observed post- transcatheter aortic valve replacement (tavr) anatomy on computed tomography (ct) and their relationship with transcatheter heart valve (thv) expansion and deployment conditions.Devices included in this study were epic, magna, magna ease, mitroflow, mosaic, perimount, trifecta, and sapien 3.The article concluded with nominal balloon filling, vtc and vts distances underestimate postprocedural distances due to thv frame underexpansion.However, postdilatation may lead to distances smaller than predicted due to thv overexpansion at the outflow level.[(b)(6)] the time frame of the study was (b)(6) 2016 and (b)(6) 2022.A total of 51 patients were included in this study.The average age was 77.7 years and the average gender was male.Comorbidities included hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease.There are no peri-procedural complications.Post-procedural complications included surgical intervention, hospitalization, aortic regurgitation, central regurgitation.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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: 17482365
• MDR Text Key: 320796815
• Report Number: 2135147-2023-03484
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1