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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Renal Failure (2041); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/01/2020

Event Type  Injury  

Event Description

The article, ¿valve-in-valve transcatheter transfemoral mitral valve implantation (viv-tmvi): characteristics and early results from nationwide registry¿, was reviewed.The article presented a retrospective, multicenter experience to describe characteristics and evaluate 30-day outcomes of valve-in-valve transcatheter transfemoral mitral valve implantation (viv-tmvi) in the polish population.Devices included in this study were agilis, hancock ii, perimount magna, epic, mosaic, labcor, ce standard, physio1, sapien 3/ultra, myval.The article concluded that short-term observation viv-tmvi is safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation.Longer observations on larger sample are warranted.[the primary and corresponding author is maciej mazurek, 1st department of cardiology, medical university of warsaw, banacha 1a, 02¿097 warszawa, poland, with corresponding email: (b)(4)@gmail.Com].The time frame of this study was from 2020 to may 2022.The study included a total of 27 patients with the average gender being female and the average age of 73 years.Comorbidities included diabetes mellitus, peripheral vascular disease, chronic kidney disease, atrial fibrillation, cerebrovascular disease, chronic lung disease, and prior pacemaker implant.

Manufacturer Narrative

Literature article: valve-in-valve transcatheter transfemoral mitral valve implantation (viv-tmvi): characteristics and early results from nationwide registry.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of valve-in-valve transcatheter transfemoral mitral valve implantation were reported in a research article.Diabetes mellitus, peripheral vascular disease, chronic kidney disease, atrial fibrillation, cerebrovascular disease, chronic lung disease, and prior pacemaker implant were reported as pre-existing conditions prior to replacement of the valves.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: 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: 17346781
• MDR Text Key: 319378834
• Report Number: 2135147-2023-03088
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/17/2023
• 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): Hospitalization; Required Intervention