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

Model Number	ESP200-23
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm epic valve was selected for implant.After the valve was implanted and the chest was closed, it was noted that there was a small hole on the leaflet.The device was removed and replaced with a 21mm epic valve to resolve the event.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was noted to have since passed away.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm epic valve was selected for implant.After the valve was implanted and the chest was closed, it was noted via echo that there was a small hole on the leaflet.The device was removed, replaced with a 21mm epic valve, and the coronary sinus was repaired to resolve the event.The patient remained hemodynamically stable throughout the procedure and there was a clinically significant delay.However, they were unable to remove the patient off of bypass after.The patient was noted to have since passed away later that day.The thought is that the increased bypass time and the valve replacement may've been the reason for the patient's death.
Additional Manufacturer Narrative
An event of a hole in the valve and patient death was reported.The investigation found that cusp 3 contained a hole.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including inspection of the sewing cuff prior to release.The cause of the hole in the cusp remains unknown; it is possible that it was due to procedural circumstances/user techniques, a sharp object coming into contact with the cusp during procedure.The cause of reported death was due to increased bypass time and the valve replacement.However this cannot be confirmed.The reported surgical intervention was a result of case-specific circumstances as device was surgically explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Based on medical review: "the exact cause of death is unknown, but may be related to a prolonged procedure time with inadequate myocardial preservation.From the appearance of the hole it appears to be a pin size hole which may be related to possibly due to inadvertent piercing of the leaflet tissue by a needle at the time of suture placement.However, the exact cause remains unknown.".

• 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: 22680039
• Report Number: 2135147-2025-04230
• Device Sequence Number: 21194093
• Product Code: LWR
• UDI-Device Identifier: 05415067033130
• UDI-Public: (01)05415067033130(17)270501
• 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: 2025
• Device Explanted 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): 12/03/2025

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: ESP200-23
• Device Catalogue Number: ESP200-23
• Device Lot Number: BR00038381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: Death; Required Intervention
• Patient Sex: Unknown