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

Catalog Number	E200-31M
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
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 31mm epic mitral valve was selected for implant.During the procedure, once the valve was implanted and the patient was taken off of bypass, it was noted via echo that there was paravalvular leak.The patient was placed back on bypass and taken back to the operating room for repair.The surgery was time was extended due to the issue and was done under extracorporeal circulation.The patient is stable.
Additional Manufacturer Narrative
An event of paravalvular leak was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, the cause of the reported perivalvular leak could not be determined.The reported hospitalization and surgical intervention were a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 31mm epic mitral valve was selected for implant.During the procedure, once the valve was implanted and the patient was taken off of bypass, it was noted via echo that there was paravalvular leak.The patient was placed back on bypass and taken back to the operating room for repair.The surgery was time was extended due to the issue and was done under extracorporeal circulation.The patient is stable.

• 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 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20989318
• Report Number: 2135147-2024-06518
• Device Sequence Number: 18104330
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)280616(10)BR00046792
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: E200-31M
• Device Lot Number: BR00046792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown