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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Degraded (1153)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Literature review: "comparison of in-hospital outcomes and long-term survival for valve-in-valve transcatheter aortic valve replacement versus the benchmark native valve transcatheter aortic valve replacement procedure" investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "comparison of in-hospital outcomes and long-term survival for valve-in-valve transcatheter aortic valve replacement versus the benchmark native valve transcatheter aortic valve replacement procedure", was reviewed.The article presented a retrospective, single center study on evaluate the efficacy, safety, and long-term survival outcomes of valve-in-valve transcatheter aortic valve replacement (viv-tavr) compared with the benchmark native valve transcatheter aortic valve replacement (nv-tavr).Devices mentioned in the article were mitroflow, carpentier edwards, st jude trifecta, hancock, and mosaic.The article concluded that viv-tavr shares the safety and efficacy profile of nv-tavr.It also represents a better early outcome but a higher non-significant long-term mortality rate.[the primary and corresponding author was didier carrié, department of cardiology, toulouse university hospital, toulouse, france, with carrie.Didier@chu-toulouse.Fr] the time frame of the study was from january 2016 and january 2020.A total of 1658 patients were included in the study, 69 patients underwent viv-tavr for failed surgical prosthesis and 1589 patients underwent tavr for native valve.Of the 69 patients who underwent viv, 6 patients (8.7%) had received an abbott device.The average age was 83.9 years and the average gender was female.Comorbidities included dyslipidemia, diabetes mellitus, arterial hypertension, smoking, chronic lung disease, atrial fibrillation, prior stroke, prior myocardial infarction, prior coronary artery bypass graft, percutaneous coronary intervention.

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 of comparison of in-hospital outcomes and long-term survival for valve-in-valve transcatheter aortic valve replacement versus the benchmark native valve transcatheter aortic valve replacement procedure were reported in a research article in a subject population with multiple co-morbidities including dyslipidemia, diabetes mellitus, arterial hypertension, smoking, chronic lung disease, atrial fibrillation, prior stroke, prior myocardial infarction, prior coronary artery bypass graft, percutaneous coronary intervention.Some of the complications reported were surgical intervention, hospitalization, acute heart failure, acute kidney injury, bleeding, and general 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: 18841159
• MDR Text Key: 337105298
• Report Number: 2135147-2024-01003
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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