MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problems Perivalvular Leak (1457); Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "mitral valve replace postoperative study at our hospital", was reviewed.This research article is a retrospective single center experience to investigate the durability of bioprosthetic valves in mitral valve position.Devices involved included magna mitral ease valve, mitris valve, epic valve, and mosaic valve.The article concluded structural valve deterioration due to leaflet dehiscence was more common in the st jude epic valve due to leaflet fixation due to pannus hyperplasia, suggesting that porcine valves may develop structural valve deterioration slightly earlier.[the primary author of this article is hirohisa murakami, md, 520 saisho, himeji, hyogo 670-0981, japan].It was reported that a total of 546 patient (mechanical valve 237, bioprosthesis 309) underwent mitral valve replacement.The mean age was 74.7.The gender of the majority of the patients' were not reported.Patient medical history included paravalvular leak, hemolysis, structural valve deterioration, chorda tendinea preserved, infectious endocarditis, and mitral regurgitation.126 patients received the st jude's epic valve.

Manufacturer Narrative

Summarized patient outcomes/complications of epic stented porcine heart valve were reported in a research article in a subject population with multiple co-morbidities including paravalvular leak, hemolysis, structural valve deterioration, chorda tendinea preserved, infectious endocarditis, and mitral regurgitation which could have been exacerbated by the procedure leading to the complications reported.Some of the complications reported were perivalvular leak, endocarditis, deterioration, perforation, leaflet dehiscence and surgical death; 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.H6 health effect - clinical code: code 4451 removed.

Event Description

The article, "mitral valve replace postoperative study at our hospital", was reviewed this research article is a retrospective single center experience to investigate the durability of bioprosthetic valves in mitral valve position.Devices involved included magna mitral ease valve, mitris valve, epic valve, and mosaic valve.The article concluded structural valve deterioration due to leaflet dehiscence was more common in the st jude epic valve due to leaflet fixation due to pannus hyperplasia, suggesting that porcine valves may develop structural valve deterioration slightly earlier.[the primary author of this article is hirohisa murakami, md, 520 saisho, himeji, hyogo 670-0981, japan] it was reported that a total of 546 patient (mechanical valve 237, bioprosthesis 309) underwent mitral valve replacement.The mean age was 74.7.The gender of the majority of the patients' were not reported.Patient medical history included paravalvular leak, hemolysis, structural valve deterioration, chorda tendinea preserved, infectious endocarditis, and mitral regurgitation.126 patients received the st jude's epic valve.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• 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: 16021356
• MDR Text Key: 305873177
• Report Number: 2135147-2022-02656
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/13/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR