MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problems Perivalvular Leak (1457); Device Stenosis (4066)

Patient Problems Stroke/CVA (1770); Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Literature article: innovative use of a self-expanding valve for valve-in-valve transcatheter mitral valve replacement: experience from a four-year single-center study.Summarized patient outcomes/complications due to replacement of an implanted surgical valve with a transcatheter competitors' j-valve were reported in a research article.The subject population had multiple co-morbidities including chronic obstructive pulmonary disease, coronary artery disease, previous coronary artery bypass, prior cva/tia, peripheral vascular disease, currently receiving dialysis, diabetes mellitus, hypertension, atrial fibrillation and previous permanent pacemaker.Some of the reasons for replacing the surgical valves were stenosis, regurgitation, surgical intervention, hospitalization, stroke 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.

Event Description

The article, "innovative use of a self-expanding valve for valve-in-valve transcatheter mitral valve replacement: experience from a four-year single-center study", was reviewed.The article presents a retrospective, single center study experience to explore the effectiveness and safety of j-valve and report the results from the four-year follow-up period of the innovative application of the transcatheter valve.Device that were included in this study were carpentier-edwards porcine and pericardial (edwards lifesciences, inc., irvine, ca, usa), hancock ii and mosaic (medtronic, minneapolis, mn, usa), epic heart valve (st jude medical, inc, st paul, mn, usa), balmedic bovine pericardial (balance medical, beijing, china), and j-valve (jc medical inc., suzhou, china).The article concluded the j-valve system is a safe and effective option for viv-tmvr: it has a high success rate and low mortality, and resulted in very few complications.The time frame of the study was from january 2019 and september 2022.The number of patients included in this study was 33 with the average age being 70.1 years and the average gender being female.Comorbidities included chronic obstructive pulmonary disease, coronary artery disease, previous coronary artery bypass, prior cva/tia, peripheral vascular disease, currently receiving dialysis, diabetes mellitus, hypertension, atrial fibrillation, previous permanent pacemaker.

• Brand Name: EPIC¿ VALVE (AORTIC)
• 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: 17213062
• MDR Text Key: 318469357
• Report Number: 2135147-2023-02811
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• 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,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EPIC STENTED PORCINE HV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• 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; Required Intervention; Disability; Hospitalization