MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	E200-33M
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 - the udi number is not known as the part and lot numbers were not provided 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, an unknown size valve was implanted in the patient.On (b)(6) 2024, the device was failing noted with valve thrombosis, leaflet was not within the range.
Additional Manufacturer Narrative
An event of thrombus was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.It was indicated that was noted with valve thrombosis and leaflet was not within the range.No additional information was provided.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 the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2024, a 33mm epic plus mitra valve was implanted in the patient.On (b)(6) 2024, the device was failing noted with valve thrombosis, leaflet was not within the range.

• Brand Name: EPIC PLUS
• 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 MN 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20774615
• Report Number: 2135147-2024-06010
• Device Sequence Number: 14577614
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: (01)05415067033109(17)270713(10)BR00039710
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00039710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2023
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Unknown