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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Degraded (1153); Perivalvular Leak (1457); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

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

Event Date 01/01/1998

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title "prosthetic valve endocarditis after aortic valve replacement: differences between biological and mechanical prostheses.

Event Description

The article, "prosthetic valve endocarditis after aortic valve replacement: differences between biological and mechanical prostheses", was reviewed.The article presented a single center, retrospective study to compare the incidence of re-intervention because of prosthetic valve endocarditis (pve) between bioprosthetic and mechanical valves.Devices included mitroflow, trifecta, sjm epic, carpentier edwards perimount magna ease, mosaic, ats mechanical valve, sjm regent, and sorin bicarbon slimline/carboseal valsalva.The article concluded that according to this single-center, observational, retrospective cohort study, aortic valve replacement (avr) using biological prosthesis is associated with re-intervention for pve compared to mechanical prosthesis.Further investigations are needed to verify these findings.[the primary and corresponding author was (b)(6) hospital eindhoven, eindhoven, the netherlands, with corresponding email: (b)(6).The time frame of the study was from january 1998 to december 2019 with the end date of follow up on (b)(6) 2020.A total of (b)(6) patients were included in the study, of which 42.4% received an abbott device.The average age was 73.1 years for the biological prosthesis group and 61.4 years for mechanical prosthesis group.The average gender was male.Comorbidities included prior cardiac surgery, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, prior stroke, peripheral arterial disease, and dialysis.

Manufacturer Narrative

Summarized patient outcomes/complications of prosthetic valve endocarditis after aortic valve replacement: differences between biological and mechanical prostheses were reported in a research article in a subject population with multiple co-morbidities including prior cardiac surgery, hypertension, diabetes mellitus, chronic obstructive pulmonary disease, prior stroke, peripheral arterial disease, and dialysis.Some of the complications reported were surgical intervention, hospitalization, bleeding, myocardial infarction, stroke, abscess, paravalvular leak, endocarditis, thrombus, pannus, cusp tear, structural valve deterioration; these complications are anticipated for the procedure and subject population.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
• 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: 18565585
• MDR Text Key: 333505292
• Report Number: 2135147-2024-00333
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• 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: 01/26/2024
• 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; Required Intervention; Hospitalization; Disability