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

Catalog Number	ESP100-23-00
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
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 supra valve was chosen for implant during an aortic valve replacement.The physician sized for the valve, placed subannular mattress sutures, and parachuted the valve into the annulus.The valve was sitting well and looked functional.As the patient came off of cardiopulmonary bypass, the transesophageal echocardiogram (tee) showed a moderate central regurgitation.As the patient was hemodynamically stable, the patient was weaned off bypass, sternotomy was closed, and patient was sent to critical care unit.On the morning of (b)(6) 2024, the transthoracic echocardiogram (tte) still showed moderate regurgitation.The patient was taken back to surgery.A tee showed that the moderate regurgitation had progressed too severe.The valve was explanted and replaced with a 23mm non-abbott valve.The echo showed trace regurgitation.The patient was reported to be doing well.The physician believed that there was something unusual with the leaflets of the 23mm epic supra valve not coapting properly.
Additional Manufacturer Narrative
An event of incomplete closure after implantation and moderate to severe regurgitation was reported.The device was returned to abbott for analysis without solution.The investigation revealed that the leaflets were severely dehydrated.The returned state of the valve precluded further functional and hemodynamic testing.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 conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC¿ SUPRA 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: 20765369
• Report Number: 2135147-2024-05962
• Device Sequence Number: 8587463
• Product Code: LWR
• UDI-Device Identifier: 05414734055642
• UDI-Public: (01)05414734055642(17)250722(10)BR00029913
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2025
• Device Catalogue Number: ESP100-23-00
• Device Lot Number: BR00029913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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: Required Intervention
• Patient Sex: Unknown