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

Catalog Number E100-33M

Device Problems Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, "transcatheter mitral valve-in-valve replacement transeptally using a novel balloon-expandable device", a 33mm epic valve was implanted in an 80-year-old male patient.Some of the complications reported were surgical intervention, hospitalization, heart failure, mitral valve regurgitation, leaflet incomplete coaptation.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Na.

Event Description

The article, "transcatheter mitral valve-in-valve replacement transeptally using a novel balloon-expandable device", was reviewed.The article presented a case study of an 80-year-old male patient.It was reported that on an unknown date, a 33mm epic valve was implanted.It was then reported 10 years post-procedure, the patient presented on an unknown date with symptomatic heart failure and severe mitral regurgitation.Transthoracic and transesophageal echocardiography revealed severe bioprosthetic valve regurgitation due to flail leaflet with an eccentric jet.A decision was made to perform a transcatheter valve-in-valve (viv) procedure with a 29mm myval heart valve.It was noted post-implant, there was no gradient and no left ventricular outflow obstruction.The article concluded that this case demonstrates the feasibility of transseptal myval viv in degenerated mitral bioprosthesis.Long-term, multicenter clinical trials are required to further confirm efficacy and safety of this novel device for the transcatheter management of valvular disease.[the primary and corresponding author was konstantinos toutouzas, school of medicine, national and kapodistrian university of athens, hippokration hospital, 114 vasilissis sophias avenue, athens 115 27, greece, with corresponding email: ktoutouz@gmail.Com].

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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: 18615599
• MDR Text Key: 334260864
• Report Number: 2135147-2024-00434
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: E100-33M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male