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 01/01/2014

Event Type  malfunction  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects reported in the article are captured under a separate medwatch report summarized patient outcomes/complications comparing barthel index with outcomes of valve replacements were reported in a research article.Some of the complications reported were pacemaker implant, cerebrovascular event, delirium, atrial fibrillation, renal replacement therapy, and paravalvular leak.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, "impact of the barthel index score and prognosis on patients undergoing transcatheter aortic valve replacement and surgical aortic valve replacement", was reviewed.The article presented a retrospective, single center study to examine the relationship between the barthel index (bi) score and postoperative outcomes in patients who underwent transcatheter aortic valve replacement (tavr) and surgical aortic valve replacement (savr).Devices included in this study were sapien xt/3, corevalve evolut r/pro/pro+, cep magna/magna ease, inspiris resilia, trifecta, mitroflow, and sjm regent.The article concluded the bi score at discharge was a significant risk factor for long-term mortality in the savr group, with a cut-off value of 60.0.(b)(6).

• 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: 18149347
• MDR Text Key: 328944330
• Report Number: 2135147-2023-05055
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 10/31/2023
• 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