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

Catalog Number	ESP200-19
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
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 19mm epic valve was selected for implant.During the procedure, while the suture needle was being used on the cuff, the outer/distal side of the ncc cuff had became torn.The valve wasn't used, the annulus was enlarged, and a 21mm epic valve was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was a 30 minute delay associated with the annulus dilation, but there were no patient consequences.The patient's condition is stable.
Additional Manufacturer Narrative
An event of device damaged during procedure was reported.It was indicated that while the suture needle was being used on the cuff, the outer/distal side of the ncc cuff had became torn.Reportedly, there was a 30 minute delay associated with the annulus dilation, but there were no patient consequences.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, the cause of the reported event was due to procedural conditions.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Per the information available abbott cannot further speculate on why the reported event occurred.
Event or Problem Description
It was reported that on (b)(6) 2025, a 19mm epic valve was selected for implant.During the procedure, while the suture needle was being used on the cuff, the outer/distal side of the ncc cuff had became torn.The valve wasn't used, the annulus was enlarged, and a 21mm epic valve was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was a 30 minute delay associated with the annulus dilation, but there were no patient consequences.The patient's condition is stable.

• 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: 21422874
• Report Number: 2135147-2025-00864
• Device Sequence Number: 7855068
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: (01)05415067033116(17)280624(10)BR00046381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/19/2025

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: ESP200-19
• Device Lot Number: BR00046381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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
• Patient Sex: Unknown