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

Catalog Number E100-31M

Device Problems Degraded (1153); Material Puncture/Hole (1504)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2019 a patient underwent a double valve replacement, using a trifecta gt aortic valve for the aortic valve replacement (avr) and an epic biocor mitral valve for the mitral valve replacement (mvr).On an unknown date it was discovered that the patient had developed aortic and mitral regurgitation.On (b)(6) 2022, the patient underwent a redo double valve replacement surgery.Upon explant, the epic mitral valve was examined and it appeared that the leaflet had become "thinner" and a hole was observed.Upon explant of the trifecta valve, pannus and a tear was observed on the non-coronary cusp.The patient received two non-abbott devices.It was reported that the patient remained stable throughout the procedure.At the time of report the patient was still in the hospital but recovering well.No additional information has been provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The date of event has been estimated to the date of explant.Related manufacturer report : (b)(6).

Manufacturer Narrative

Explant was reported due to aortic regurgitation, a hole in the cusp, and thinning tissue.The investigation found that cusp 1 was torn.The base of all three cusps had thinning and loss of collagen fibers.Cusp 3 had a thin layer of fibrin.There was no acute inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.There is no indication of a product quality issue with regards to manufacture design or labeling.

Event Description

N/a.

• 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: 14307136
• MDR Text Key: 292581918
• Report Number: 2135147-2022-00240
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2022
• Device Catalogue Number: E100-31M
• Device Lot Number: 6775086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 85 YR