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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Perivalvular Leak (1457); Central Regurgitation (4068)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Pneumonia (2011); Renal Failure (2041); Sepsis (2067); Cognitive Changes (2551); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Respiratory Insufficiency (4462)

Event Date 11/01/2009

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of aortic valve replacement was reported in a research article.Some of the complications reported were left bundle branch block, new permanent pacemaker, stroke, life-threatening bleed, atrial fibrillation, respiratory failure, acute renal failure, delirium, pneumonia, sepsis, multisystem organ failure, paravalvular leak, aortic regurgitation, 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

Event Description

The article, "aortic valve versus root surgery after failed transcatheter aortic valve replacement", was reviewed.The article presented a retrospective, multicenter study to determine outcomes of aortic valve replacement (avr) versus root replacement after transcatheter avr (tavr) explantation because they remain unknown.Devices included in this study were sapien/sapien 3/sapien xt, corevalve, evolut r/pro/pro+, lotus, acurate neo, direct flow, jenavalve, portico, engager, sjm mechanical valve, cyrolife on-x, ce perimount, ce magna/magna ease, edwards inspiris, medtronic avalus, medtronic mosaic, medtronic hancock ii, freedom solo, sorin mitroflow, sjm trifecta, edwards intuity, ln perceval, freestyle, bioconduit, and autograft.The article concluded in the explant-tavr registry, avr and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities.Further investigations are necessary to identify patients at risk of root replacement in tavr explant.[the primary and corresponding author was keti vitanova, department of cardiovascular surgery, german heart center munich, lazarettsr 36, de-80636, munich, germany, with corresponding e-mail: vitanova@dhm.Mhn.De].

• 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: 18234076
• MDR Text Key: 329315522
• Report Number: 2135147-2023-05253
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• 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: 11/06/2023
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Required Intervention