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

Catalog Number	ESP200-25
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	12/11/2024
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 11 december 2024, a 25mm epic plus supra valve was selected for implant.The valve was implanted.However, "owing to fraility of aorta patients aortic annulus was giving away it might be due to stenttramic stiffness," cardioplegia was administered and the valve was explanted.It was further described that the patient's aorta was found to be too fragile to stitch the epic valve into place.The patient then underwent pericardial re-construction of the annulus in a continuous fashion with a 5-0 prolene suture.Then, a new 10mm epic plus supra valve was successfully implanted.A delay in overall procedure time was reported.The patient status was reported as unknown.
Additional Manufacturer Narrative
An event of valve explant was reported.It was indicated that the owing to fraility of aorta patients aortic annulus was giving away it might be due to stenttramic stiffness.The device was returned to abbott for investigation which revealed that the sewing cuff was intact.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 surgical intervention was case specific where device was explanted.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 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: 21068731
• Report Number: 2135147-2025-00058
• Device Sequence Number: 8409473
• Product Code: LWR
• UDI-Device Identifier: 05415067033147
• UDI-Public: (01)05415067033147(17)280605(10)BR00046049
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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 Catalogue Number: ESP200-25
• Device Lot Number: BR00046049
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male