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 08/01/2019

Event Type  malfunction  

Event Description

The article, "clinical outcomes following transcatheter mitral valve-in-valve replacement using a meril myval transcatheter heart valve", was reviewed.The article presented a retrospective, single center study to report in-hospital, 30-day, and 1-year outcomes of myval patients who underwent transcatheter mitral valve-in-valve (tmviv) in a single tertiary care centre in india.Devices included in the study were epic, biocor, carpentier edwards perimount, hancock, and magna.The article concluded that tmviv replacement with a meril myval can be safely performed with high technical success, and low 30-day and 1-year mortality.[(b)(6)].The time frame of the study was from (b)(6) 2019 to (b)(6) 2022.A total of 20 patients were included in the study, of which 5 (25%) received an abbott device.The average age was 64.4 years and the average gender was female.Comorbidities included diabetes mellitus, systemic hypertension, dyslipidemia, prior coronary artery bypass grafting, chronic obstructive pulmonary disease, severe pulmonary arterial hypertension.

Manufacturer Narrative

Summarized patient outcomes/complications of transcatheter mitral valve-in-valve (tmviv) in a single tertiary care centre in india were reported in a research article "clinical outcomes following transcatheter mitral valve-in-valve replacement using a meril myval transcatheter heart valve" in a subject population with multiple co-morbidities including diabetes mellitus, systemic hypertension, dyslipidemia, prior coronary artery bypass grafting, chronic obstructive pulmonary disease, severe pulmonary arterial hypertension.Some of the complications reported were mitral regurgitation, mitral valve stenosis, surgical intervention, hospitalization; 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: 18614833
• MDR Text Key: 335096771
• Report Number: 2135147-2024-00421
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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?: 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
• Initial Date Manufacturer Received: 01/22/2024
• 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