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

Catalog Number	EMAX-23
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
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 23mm epic max valve was chosen for implant for a bicuspid aortic valve.The valve was implanted and tied down.After the valve was seated and the sutures were tied, it was noted that the retrograde cardioplegia was not coming freely out of the right coronary artery (rca), and there was concern of possible obstruction of the ostium to the rca.It was believed that due to the bicuspid aortic valve anatomy the coronary ostium for the rca was not in the traditional location.The valve was removed from the patient and replaced with a 21mm non-abbott valve while the patient remained on cardiopulmonary bypass.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects reported.The patient status was reported as stable.
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm epic max valve was chosen for implant for a bicuspid aortic valve.The valve was implanted and tied down.After the valve was seated and the sutures were tied, it was noted that the retrograde cardioplegia was not coming freely out of the right coronary artery (rca), and there was concern of possible obstruction of the ostium to the rca.It was believed that due to the bicuspid aortic valve anatomy the coronary ostium for the rca was not in the traditional location.The valve was removed from the patient and replaced with a 21mm non-abbott valve while the patient remained on cardiopulmonary bypass.The patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects reported.The patient status was reported as stable.
Additional Manufacturer Narrative
It was reported upon the retrograde cardioplegia was not coming freely out of the right coronary artery after suturing the valve, and the valve being removed from patient as there was concern of possible obstruction of the ostium.There were no adverse patient effects reported.The investigation at abbott found that there was a cut noted on one of the stent posts.No other anomalies were noted to the valve.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 noted damage is possibly from implant or explant of the valve.Information from field indicated that it was believed that due to the bicuspid aortic valve anatomy the coronary ostium for the rca was not in the traditional location.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19043306
• Report Number: 2135147-2024-01538
• Device Sequence Number: 7355077
• Product Code: LWR
• UDI-Device Identifier: 05415067045478
• UDI-Public: (01)05415067045478(17)270919(10)BR00040682
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/22/2024

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-23
• Device Lot Number: BR00040682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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
• Patient Age: 56 YR
• Patient Sex: Male