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

Model Number	EMAX-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of difficulty closing the aorta was reported.Information from the field indicated that there was difficulty closing the aorta due to the bulky stent posts, even after using the double-ended sizers.The decision was made to enlarge the aortic root and use non-abbott patches.The valve was able to be successfully implanted in the aortic valve with excellent results.A returned device inspection, to rule out any device-related causes, 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.Based on the available information, the cause of the reported incident could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the aortic root was enlarged using a patch.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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) 2025, a 21mm epic max valve was selected for implant.The valve was sized using an epic max sizer set.It was noted during procedure, that there was difficulty closing the aorta due to the bulky stent posts, even after using the double-ended sizers.The decision was made to enlarge the aortic root and use non-abbott patches.The valve was able to be successfully implanted in the aortic valve with excellent results.There was no initial or prolonged hospitalization due to this event.There is no allegation of malfunction against the 21mm epic max valve or procedure.The patient was in stable condition at the time of report.

• Brand Name: EPIC MAX VALVE (AORTIC)
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22056179
• Report Number: 2135147-2025-02656
• Device Sequence Number: 15219533
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)271203
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: EMAX-21
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00042236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPIC MAX SIZER SET, EMAX-1000 (LOT: 10441041)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown