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

Catalog Number	EMAX-25
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
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 25mm epic max valve was chosen for implant during an aortic valve replacement.There was no damage noted to the packaging or the product box, and the qa seal was still intact.There was no damage noted to the device during device preparation.During the procedure, the valve was being implanted, and it was then noted that the sewing cuff was damaged.The valve was removed and replaced with another 25mm epic max valve, which was successfully implanted.The patient remained stable throughout the procedure.The patient was discharged without any complications or delay.
Additional Manufacturer Narrative
An event of torn cuff (sewing cuff was damaged) did not confirm.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The valve was inspected and the cuff was intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications prior to shipment.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information and returned device analysis, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 20589863
• Report Number: 2135147-2024-05525
• Device Sequence Number: 6558400
• Product Code: LWR
• UDI-Device Identifier: 05415067045454
• UDI-Public: (01)05415067045454(17)280204(10)BR00042980
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EMAX-25
• Device Lot Number: BR00042980
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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
• Patient Sex: Unknown