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

Catalog Number	EMAX-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/07/2024
Type of Reportable Event	Death
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 21mm epic max valve was chosen for implant.The patient was presented with small aortic root, requiring enlargement.The 21mm epic max valve was implanted.However, the patient started bleeding and atrioventricular dissection was noticed.The valve was explanted, and pericardial patch repair was performed.A replacement 19mm epic max valve was implanted.
Additional Manufacturer Narrative
An event of explant due to bleeding from the aortic root was reported.Information from the field indicated that post-operatively the patient developed an ischemic lower extremity limb as a complication from a iabp that led to sepsis and end-organ injury and ultimately a fatality.The device was returned to abbott for investigation which revealed that the sewing cuff was intact and contained blood/bodily fluid.There were no perforations or tears observed and the cusps were mobile.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.
Event or Problem Description
It was reported that on (b)(6) 2024, a 21mm epic max valve was chosen for implant in a 64-year-old female patient) with a history of aortic insufficiency, coronary artery disease and hypertension.The patient underwent an aortic valve replacement (avr) with a concomitant coronary artery bypass grafting (cabg) to the left anterior descending coronary artery (lad) using the left internal mammary artery (lima).The patient had a small aortic root with thin aortic tissue and an aortic enlargement was required.The aortic valve was sized for a 21 mm epic max valve using the replica sizer end of the epic max sizer set.The 21 mm sizer fit was good, and a decision was made to implant the 21mm epic max valve.The epic max 21mm was implanted without difficulty with the sutures secured using cor-knots.After coming off cardiopulmonary bypass it was noted that there was bleeding from the base of the aorta in the non-coronary sinus with visible pledgets consistent with an aortic-ventricular separation.The patient was placed back on cardiopulmonary bypass and the epic max 21mm valve was removed to expose the area of bleeding.The aortic bleeding site was repaired with autologous pericardial tissue and the valve was resized.Although an epic max 21mm valve was able to be fitted a decision was made to implant instead an epic max 19mm valve.The patient had difficulty coming off cardiopulmonary bypass due to the prolonged procedure and ultimately an intra-aortic balloon pump (iabp) was placed and the patient successfully came off cardiopulmonary bypass.Over the next few days the myocardial function recovered.However, the patient developed an ischemic lower limb as a complication from the iabp and needed to undergo a lower extremity amputation.However, a decision was made not to amputate the lower extremity and the patient developed sepsis with end-organ failure due to the ischemic lower extremity.The patient subsequently passed away.This issue reportedly caused a clinically significant delay due to having to remove, repair, and replace valve.

• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18801100
• Report Number: 2135147-2024-00919
• Device Sequence Number: 17936634
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)270604(10)BR00038722
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EMAX-21
• Device Lot Number: BR00038722
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female