BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3980762 · Received August 5, 2014

    Report

    Report Number
    2025587-2014-00543
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 6, 2014
    Report Date
    September 16, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE REPORTED INFORMATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. AORTIC REGURGITATION CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS OBTAINED AND HAS BEEN ADDED TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICAL STUDY SITE SUBSEQUENTLY CONFIRMED THE REPORTED LEAK WAS PARAVALVULAR. NO SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SEVERE AORTIC REGURGITATION WAS OBSERVED FOLLOWING DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE. A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE TO RESOLVE THE REGURGITATION. NO SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458354 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention