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

Catalog Number	ESP200-23
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/19/2024
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 plus supra valve was implanted.On (b)(6) 2024, during routine examination of the valve, leaflet tear was observed; the patient also had associated shortness of breath.The cause of the tear was suspected as either "implanted valve or some infections." the infection was further described as "ar induced infection." the epic valve was explanted and a non-abbott onx mechanical valve was implanted.No patient consequences were reported.
Additional Manufacturer Narrative
Explant due to shortness of breath and leaflet tear was reported.The investigation found all 3 cusps were mobile when manually manipulated.The inflow and outflow surfaces were unremarkable.No tear was identified in any of the cusps.The sewing cuff was intact.There was essentially no pannus formation.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 reported event could not be determined.There is no indication of a product quality issue with regards to manufacture design or labeling.

• 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: 19950032
• Report Number: 2135147-2024-03877
• Device Sequence Number: 8898138
• Product Code: LWR
• UDI-Device Identifier: 05415067033130
• UDI-Public: (01)05415067033130(17)270531(10)BR00038955
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Catalogue Number: ESP200-23
• Device Lot Number: BR00038955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male