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

Catalog Number	EMAX-21
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 - the udi number is not known as the part and lot numbers were not provided.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 an unknown size epic max valve was implanted in the fall of 2023.The transvalvular gradient of following implant was less than 10 mmhg.Several months later, the patient underwent evaluation with a transthoracic echocardiogram (tte) demonstrating an elevated transvalvular gradient.The patient was scheduled for a tee to further assess the valve performance.
Additional Manufacturer Narrative
An event of valve stenosis 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.Based on the information received, the cause of the reported incident 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 (b)(6) 2023, a 21mm epic max valve was implanted in the patient.The transvalvular gradient of following implant was less than10 mmhg.On (b)(6) 2024, a follow up transthoracic echocardiogram (tte) was conducted and the gradient was 92/59.The patient was put on coumadin and scheduled for a tee to further assess the valve performance.On (b)(6) 2024, tee showed the gradient was down to peak of 39.The patient was reported stable and recovering.

• 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: 19395653
• Report Number: 2135147-2024-02391
• Device Sequence Number: 7753823
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)270528(10)BR00038671
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/26/2024

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-21
• Device Lot Number: BR00038671
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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