MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	E200-29M
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/12/2024
Type of Reportable Event	Death
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 27mm epic valve was selected for implant.During the procedure, sutures were placed on the mitral ring and the 27mm epic valve was parachuted down into the annulus and the sutures were tied.Left arteriorrhaphy was then performed followed by maneuvers to remove air, and removal of the aortic clamp.The first attempt to take the patient off of cardiopulmonary bypass was halted due tot he patient going into cardiac arrest.Custodiol was administered and the prosthesis was checked.Echocardiogram revealed that one of the leaflets showed restricted mobility, reducing the flow of blood from the atrium to the left ventricle.Another attempt to take the patient off cardiopulmonary bypass, but again was not possible.Custodiol was administered again and the valve was replaced with 29mm epic valve.The same result occurred while trying to take the patient off of cardiopulmonary bypass.There was poor mobility of the prothesis leaflets with biventricular dysfunction.A 40mm intra-aortic balloon pump was implanted in the left femoral artery, all supports were adjusted, and another attempt to come off cardiopulmonary bypass was made without success.The patient ended up passing away.
Event or Problem Description
It was reported that on (b)(6) 2024, a 27mm epic valve was selected for implant.During the procedure, sutures were placed on the mitral ring and the 27mm epic valve was parachuted down into the annulus and the sutures were tied.Left arteriorrhaphy was then performed followed by maneuvers to remove air, and removal of the aortic clamp.The first attempt to take the patient off of cardiopulmonary bypass was halted due to the patient going into cardiac arrest.Custodiol was administered and the prosthesis was checked.Echocardiogram revealed that one of the leaflets showed restricted mobility, reducing the flow of blood from the atrium to the left ventricle.Another attempt to take the patient off cardiopulmonary bypass, but again was not possible.Custodiol was administered again and the valve was replaced with 29mm epic valve.The same result occurred while trying to take the patient off of cardiopulmonary bypass.There was poor mobility of the prothesis leaflets with biventricular dysfunction.A 40mm intra-aortic balloon pump was implanted in the left femoral artery, all supports were adjusted, and another attempt to come off cardiopulmonary bypass was made without success.The patient ended up passing away.
Additional Manufacturer Narrative
An event of leaflets not being coapting after implant, cardiac arrest and patient death was reported.A returned device assessment could not be performed as the device 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.This includes functional testing of the device which ensures proper cuspal coaptation and hemodynamic performance.Based on the information received, the cause of the reported event could not be conclusively determined.Per the information available abbott cannot further speculate on why the reported event occurred.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: "the exact cause of the difficulty separating from cpb is unknown, but most likely relates to inadequate myocardial preservation at the time of cpb resulting in global hypokinesis and myocardial dysfunction leading to the fatality.With decreased cardiac flow there is likely going to be decreased blood flow cross the implanted mitral epic valves which would explain the decrease in leaflet mobility.This fatality is adjudicated as procedure related and not related to the implanted epic mitral valve.".

• Brand Name: EPIC PLUS
• 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: 20857525
• Report Number: 2135147-2024-06138
• Device Sequence Number: 15635840
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)280415(10)BR00044417
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Catalogue Number: E200-29M
• Device Lot Number: BR00044417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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: Death
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 60 KG