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

Catalog Number E100-27M

Device Problems Material Split, Cut or Torn (4008); Central Regurgitation (4068)

Patient Problems Angina (1710); Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2019, a 27mm epic valve was implanted in the mitral position during a double valve replacement procedure.On a later date, the patient had mitral valve regurgitation on echocardiography.The patient also experienced chest pain on exertion and shortness of breath.Approximately 6 months later, on (b)(6) 2024, the valve was explanted, and a tear was observed at the cuff of the valve and on the cusp of the valve.A 23mm non-abbott valve was implanted as replacement.The patient was hospitalized and stable.

Manufacturer Narrative

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

• 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: 19073044
• MDR Text Key: 339736310
• Report Number: 2135147-2024-01613
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734027526
• UDI-Public: (01)05414734027526(17)230521(10)7040450
• 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
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Catalogue Number: E100-27M
• Device Lot Number: 7040450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female