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

Catalog Number	EMAX-23
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 18 june 2024, a 23mm epic max valve was implanted in a patient with no apparent concern.Upon transesophageal echocardiogram (tee) evaluation, a prominent leak was observed starting at the center of the valve which continued down toward the leaflet.This was not a paravalvular leak.It was thought that this leak may have been leaflet related.Patient was put back on bypass and a second 23mm epic max was implanted.Tee revealed normal flow and valve appearance.Patient was extubated and is recovering in stable condition.
Additional Manufacturer Narrative
An event of central 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.
Additional Manufacturer Narrative
H6: health effect clinical code: removed code 4582 no clinical signs, symptoms or conditions.An event of central regurgitation post implant was reported.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 2.2%.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19716123
• Report Number: 2135147-2024-03330
• Device Sequence Number: 8274557
• Product Code: LWR
• UDI-Device Identifier: 05415067045478
• UDI-Public: (01)05415067045478(17)271018(10)BR00041250
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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-23
• Device Lot Number: BR00041250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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 Age: 77 YR
• Patient Sex: Male