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

Catalog Number	EMAX-19
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.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 19mm epic max valve was chosen for a procedure.The body surface area (bsa) was 1.83 and the aortic valve was suitable for epic max valve.The valve was implanted according instructions for use (ifu).After closing, the transesophageal echocardiogram (tee) showed unpredictable severe central jet from newly implanted valve.The jet was clinically unacceptable from heart team and they decided to explant the valve.The valve was explanted and a new 19mm epic max valve was implanted.The central jet was mild after the procedure and heart team was satisfied with the result.After the procedure, heart team checked the explanted valve and they claimed one leaflet of biological valve was short and coaptation defect.There was some delay in the explanation and reimplantation procedure.The patient remained hemodynamically stable throughout the procedure.The patient was reported in intensive care unit (icu).
Additional Manufacturer Narrative
An event of incomplete coaptation was reported.Imaging was also received from the field and reviewed.The valve was returned to abbott for analysis and the investigation revealed that all three cusps were flexible and contained no tears, perforations or anomalies.All cusps were mobile when manually manipulated.Functional testing at the time of manufacturing and upon return to abbott indicated that the valve functioned normally.During this test, which ensures proper cuspal coaptation and hemodynamic performance, the valve was placed in a pulse duplicator filled with saline.The conditions included a beat rate of 70 ± 1 bpm, a flow rate of 5.0 ± 0.2 lpm, and a mean aortic pressure of 100 +10/-0 mmhg.Under these conditions, the leaflets appeared to coapt such that the regurgitant fraction value was 1.5%.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event could not be conclusively determined.
Event or Problem Description
N/a.

• Brand Name: EPIC MAX VALVE (AORTIC)
• 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: 19844653
• Report Number: 2135147-2024-03652
• Device Sequence Number: 6627986
• Product Code: LWR
• UDI-Device Identifier: 05415067045461
• UDI-Public: (01)05415067045461(17)271031(10)BR00041811
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/24/2024

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: EMAX-19
• Device Lot Number: BR00041811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Female