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

Model Number	EMAX-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	04/25/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm epic max valve was selected for implant in a patient who had undergone a prior tavi procedure.Post-procedure, the patients coronary artery was noted to have become occluded.The patient passed away as a result.The physician believes that the artery was blocked due to oversizing of the bioprosthetic and because the tavi was removed.It was also noted as a possibility that tissue fragments may have entered the coronary artery during the removal of the tavi.The physician believes that the epic device functioned as intended and that the death was not related to a product malfunction.
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.
Additional Manufacturer Narrative
It was reported that the patients coronary artery was noted to have become occluded one day after epic valve implant.The patient expired as a result of the obstruction.A review of the patient¿s intraoperative video showed that some of the tissue fragments from the tavi removal may have remained.Reportedly, the physician believed that the artery was blocked due to oversizing of the bioprosthetic of because of the residual tissue fragments from the tavi removal.The device remained implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Requests were made for additional procedural details surrounding the case (e.G., operative notes, procedure imaging), however this information was not supplied by the site.Based on the information received and medical review performed at abbott, it is difficult to determine with certainty the exact cause of the reported coronary obstruction and patient death.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
On an unknown date, a non-abbott balloon expandable tavi procedure was performed.At some point, the valve was noted to have had a failure and needed to be replaced.On (b)(6) 2025, a 19mm epic max valve was selected for implant.During the procedure, the physician removed the tavi and fragemtns of tissue after the explant, after which the epic was implanted without issue.On (b)(6) 2025, the patients coronary artery was noted to have become occluded.A ct was performed and no major thrombus was found.The patient ended up passing away as a result of the obstruction.The physician believes that the artery was blocked due to oversizing of the bioprosthetic.Review of the patient¿s intraoperative video showed that the some of the tissue fragments from the tavi removal may have remained.The physician believes that the artery was blocked due to oversizing of the bioprosthetic of because of the residual tissue fragments from the tavi removal.The physician believes that the epic device functioned as intended and that the death was not related to a product malfunction.

• 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: 22360167
• Report Number: 2135147-2025-03554
• Device Sequence Number: 12938087
• Product Code: LWR
• UDI-Device Identifier: 05415067045461
• UDI-Public: (01)05415067045461(17)281215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/08/2025

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-19
• Device Catalogue Number: EMAX-19
• Device Lot Number: BR00049698
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown