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

Catalog Number E100-25M

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Mitral Valve Stenosis (1965); Syncope/Fainting (4411); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 29 january 2020, a 25mm epic valve was successfully implanted in a bilateral leaflet-preserving mitral valve replacement procedure.The native valve annulus was measured to be 28mm.On (b)(6) 2023, the patient presented with shortness of breath and syncope.An echocardiogram was taken, and calcification was seen.It was thought that two of the valve cusps had limited mobility, which contributed to mitral stenosis.Aortic stenosis was also observed.It was noted that posterior leaflet preservation and valve cusp fusion had occurred, as well as anterior leaflet preservation and leaflet fusion in the anterior leaflet area.On (b)(6) 2023, the epic valve was explanted, and an unknown valve was implanted as a replacement.The posterior and anterior leaflets were also sutured to treat tricuspid regurgitation (tr).Stenosis was observed on the explanted epic valve.The patient was reported as stable.

Manufacturer Narrative

Explant due to stenosis was reported.The investigation found that there was fibrous pannus ingrowth on the outflow surface of cusps 1 and 2 which fused the commissure and limited the mobility of the cusps.There was outflow thrombus on cusps 1 and 3 and a thin layer of fibrous pannus on the inflow surface of cusp 1.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The pannus fusing cusps 1 and 2 together could have contributed to the reported stenosis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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: 17204209
• MDR Text Key: 317935122
• Report Number: 2135147-2023-02783
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Catalogue Number: E100-25M
• Device Lot Number: 7047205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• 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
• Patient Age: 77 YR
• Patient Sex: Female