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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2012

Event Type  malfunction  

Event Description

The article, "comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the avenger multicentre registry", was reviewed.The article presented a retrospective, multicenter study to compare outcomes of using two self-expanding transcatheter heart valve (thv) systems for valve-in-valve (viv).Devices included in this study were acurate neo/neo2, evolut r/pro/pro+, ce sav/standard, epic/epic supra, hancock, magna/magna ease, mosaic, perimount, soprano, crown, mitroflow, trifecta, freedom solo, freestyle, pericarbon freedom, and unknown.The article concluded that viv tavi using either acurate or evolut thvs showed similar procedural outcomes.However, a true id >19 mm was associated with higher device success among acurate recipients, whereas in patients with a true id =19 mm, device success was higher when using evolut.[the primary and corresponding author was won-keun kim, kerckhoff heart center, department of cardiology, benekestrasse 2-8, 61231, bad nauheim, germany, with corresponding e-mail: w.Kim@kerckhoff-klinik.De] the time frame of the study was from 2012 to 2023.A total of 835 patients were included in this study, of which 150 were previously implanted an abbott device before undergoing viv with a non-abbott device (22 were epic/epic supra and 128 were trifecta).The average age was 79 years and the majority gender was male.Comorbidities included coronary artery disease, prior pacemaker, atrioventricular block, right bundle branch block, aortic regurgitation.

Manufacturer Narrative

Summarized patient outcomes/complications of sing two self-expanding transcatheter heart valve (thv) systems for valve-in-valve (viv) were reported in a research article "comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: the avenger multicentre registry" in a subject population with multiple co-morbidities including coronary artery disease, prior pacemaker, atrioventricular block, right bundle branch block, aortic regurgitation.Some of the complications reported were surgical intervention (valve-in-valve), hospitalization, aortic stenosis, aortic regurgitation; 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: 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: 19076198
• MDR Text Key: 340587698
• Report Number: 2135147-2024-01625
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• 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: 03/18/2024
• 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