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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title: impact of bioprosthetic valve fracture on hemodynamics in transseptal mitral valve-in-valve replacement.

Event Description

The article, "impact of bioprosthetic valve fracture on hemodynamics in transseptal mitral valve-in-valve replacement", was reviewed.The article presented a retrospective, single center study on experiences with bioprosthetic valve fracture (bvf) performed by high-pressure postdilation (hppd) in transcatheter mitral valve-in-valve (mviv).Devices included in this study were sapien 3/3 ultra, sjm biocor/epic, carpentier-edwards perimount/pericardial/magna, and medtronic hancock ii/mosaic.The article concluded that the study demonstrated that bvf following mviv was safe and led to an acute decrease in mean gradient.[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 e-mail: krishna2@ccf.Org].

Manufacturer Narrative

Summarized patient outcomes/complications of thv - epic biocor were reported in a research article in a subject population with multiple co-morbidities including stenosis, regurgitation, and ejection fraction.Some of the peri-and post-procedural complications reported were heart failure, hospitalization, stenosis, regurgitation, valve-in-valve (surgical intervention), improper use, and device damaged by another device; 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. based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the instructions for use, ifu biocor supra, arten100121084, revision c, it stated, "precaution: do not attempt to repair a valve.Damaged valves must not be used." this is considered as an improper or incorrect procedure or method of the device.However, it was unable to determine if an improper or incorrect procedure or method contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

• 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: 18256493
• MDR Text Key: 329606219
• Report Number: 2135147-2023-05315
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 01/02/2024
• 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