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

Model Number	E100-31M-00
Medical Device Problem Codes	Degraded (1153); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	02/01/2022
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 an unknown date and year, a 31mm stentec porcine,mit,epic was implanted.On an unknown date the patient reported that the valve malfunction.It is unknown if the device was replace.Patient status is unknown.
Additional Manufacturer Narrative
An event of device failure was reported.Information from the patient was received that the device was failing approximately two years post-procedure.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.Although requested, no further information was received regarding this event.However, the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the limited information received, the cause of the reported event 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
It was reported that on an unknown date and year, a 31mm stentec porcine, mit, epic was implanted.On an unknown date the patient reported that the valve malfunction.It is unknown if the device was replace.Patient status is unknown.
Event or Problem Description
It was reported that in (b)(6) 2021, a 31mm epic valve was implanted.One year post implant, the patient began suffering from shortness of breath, lack of stamina, and generally feeling poorly.A tee was performed and revealed that the mitral valve was leaking backwards.In (b)(6) 2024, a valve-in-valve procedure was conducted using a non-abbott valve.The procedure went well with no complications.The patient is stable, but was noted to have balance problems.It's unsure not sure if this is related to the device.
Additional Manufacturer Narrative
An event of dyspnea, lack of stamina, mitral valve regurgitation one-year post-procedure was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.Although requested, no further information was received regarding this event.However, the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the limited information received, the cause of the reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as a valve-in-valve procedure was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Additional Manufacturer Narrative
An event of dyspnea, lack of stamina, mitral valve regurgitation one-year post-procedure was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.Although requested, no further information was received regarding this event.However, the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the limited information received, the cause of the reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as a valve-in-valve procedure was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that in (b)(6) 2021, a 31mm epic valve was implanted.One year post implant, the patient began suffering from shortness of breath, lack of stamina, and generally feeling poorly.A tee was performed and revealed that the mitral valve was leaking backwards.In (b)(6) 2024, a valve-in-valve procedure was conducted using a non-abbott valve.The procedure went well with no complications.The patient is stable but was noted to have balance problems.It's unsure not sure if this is related to the device.

• 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: 20007202
• Report Number: 2135147-2024-04035
• Device Sequence Number: 4431462
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: (01)05414734055604(17)221118
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/21/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: E100-31M-00
• Device Catalogue Number: E100-31M-00
• Device Lot Number: BR00018879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 03/18/2025; 08/08/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/05/2024; 04/11/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2018
• 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: Disability; Other; Required Intervention
• Patient Sex: Unknown