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

Catalog Number	ESP200-21
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: patient age was estimated.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) 2025, a 21mm epic plus supra valve was chosen for implant.After sizing was performed, the 21mm epic plus supra valve could not pass through the sino-tubular junction.A decision was made to replace the 21mm epic plus supra valve with a 21mm non-abbott valve.The patient remained hemodynamically stable throughout the procedure.
Event or Problem Description
It was reported that on 03 february 2025, a 21mm epic plus supra valve was chosen for implant.Sizing was performed with an epic plus e2000 sizer set and the 21mm size passed narrowly through the patient's anatomy with the supra valve replica end.The 21mm epic plus supra valve could not pass through the sino-tubular junction.The physician believed a 19mm epic plus supra might have been more appropriate.A decision was made to replace the 21mm epic plus supra valve with a 21mm non-abbott valve.The patient remained hemodynamically stable throughout the procedure.The patient status was reported discharged.
Additional Manufacturer Narrative
An event of resistance was felt while suturing the valve was reported.The investigation confirmed that the returned valve met dimensional specifications.It was indicated that the valve could not pass through the sino-tubular junction.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.The cause of the reported event could not be conclusively determined.Per the information available abbott cannot further speculate on why the reported event occurred.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the information available abbott cannot further speculate on why the reported event occurred.

• 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: 21492148
• Report Number: 2135147-2025-01018
• Device Sequence Number: 11757952
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: (01)05415067033123(17)280506(10)BR00045714
• 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): 04/03/2025

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: ESP200-21
• Device Lot Number: BR00045714
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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 Age: 70 YR
• Patient Sex: Female