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

Catalog Number	E100-33M-00
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/22/2024
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) 2024, a 33mm epic mitral valve was chosen for implant.The patient was presented with a non-abbott annuloplasty ring that was placed 10 years ago.During the procedure, the epic valve was implanted, using a total of 27 stitches.After coming off cardiopulmonary bypass, the patient was found to have mild central mitral valve regurgitation (mr).Considering the additional risks for replacing the implanted valve, a decision was made to not explant the valve although the presence of mild mr was considered unacceptable.The patient was reported to be discharged.The mr prior to discharge was observed to be at grade mild-trace.
Event or Problem Description
It was reported that on 22 february 2024, a 33mm epic mitral valve was chosen for implant.The patient was presented with a non-abbott annuloplasty ring that was placed 10 years ago.During the procedure, the epic valve was implanted, using a total of 27 stitches.After coming off cardiopulmonary bypass, the patient was found to have mild central mitral valve regurgitation (mr).Considering the additional risks for replacing the implanted valve, a decision was made to not explant the valve although the presence of mild mr was considered unacceptable.The patient was reported to be discharged.The mr prior to discharge was observed to be at grade mild-trace.
Additional Manufacturer Narrative
An event of mild central mitral valve regurgitation post implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, to see if there were any valve abnormalities could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including functional testing prior to release form abbott.This test ensures proper cuspal coaptation and hemodynamic performance.Based on the information associated with this complaint, the exact cause of the reported event could not conclusively be determined.

• 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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18923664
• Report Number: 2135147-2024-01201
• Device Sequence Number: 15055499
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: (01)05414734055611(17)261214(10)BR00036169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00036169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male