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 Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/01/2016

Event Type  malfunction  

Event Description

The article, ¿mid-term outcome and its predictors following transseptal mitral valve-in-valve replacement¿, was reviewed.The article presented a retrospective single center experience to investigate incidence of death and heart failure hospitalization (hfh) and its predictors in the midterm period (~2 years) regarding transcatheter mitral valve-in-valve (mviv) replacement procedures.Devices included in the study were perimount/pericardial/magna (carpentier-edwards), biocor/epic (sjm/abbott), hancock ii/mosaic (medtronic), sapien 3/sapien 3 ultra (edwards lifesciences).The article concluded the study provided new insights into mid-term outcomes following ts-mviv and provides caution regarding anticoagulation and bleeding in this group.Larger multicenter studies with longer follow-up are warranted to confirm findings.[the primary and corresponding author was amar krishnaswamy, department of cardiovascular medicine, heart, vascular and thoracic institute, cleveland clinic, 9500 euclid avenue, j2-3, cleveland, ohio 44195, usa, with corresponding email: krishna2@ccf.Org].

Manufacturer Narrative

It was reported that (b)(4) patients were included in this study of ¿mid-term outcome and its predictors following transseptal mitral valve-in-valve replacement¿ between september 2016 and april 2022, and (b)(4) patients were implanted using an abbott device.Summarized patient outcomes/complications of coronary artery bypass, prior pacemaker implant, atrial fibrillation, anemia, and mitral regurgitation.Some of the complications reported were mitral regurgitation, mitral valve stenosis, surgical intervention, and hospitalization.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.Literature attachment: article title "mid-term outcome and its predictors following transseptal mitral valve-in-valve replacement.".

• 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: 17767766
• MDR Text Key: 323763510
• Report Number: 2135147-2023-04046
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 08/24/2023
• 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