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

Catalog Number	E100-33M-00
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 33mm epic valve was implanted in the patient.On an unknown date, severe prosthetic valve deterioration with severe mitral regurgitation was noted but no active evidence of endocarditis.The valve was explanted and a 33mm non-abbott valve was implanted.The explanted valve had thickened leaflets.The patient was reported stable and recovering.
Additional Manufacturer Narrative
An event of severe mitral regurgitation and thickened leaflets were reported.The patients medical history included hypertension, complete heart block, atrial fibrillation, anemia, and renal mass.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.From information received, structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors which can result in stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The reported medical intervention was result of case specific circumstance as the surgical removal of device during the procedure.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 respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• Brand Name: EPIC¿ VALVE (MITRAL)
• Common Device Name: 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: 20945324
• Report Number: 2135147-2024-06419
• Device Sequence Number: 4592150
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: (01)05414734055611(17)250722(10)BR00029994
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2025
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00029994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female