BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4012370 · Received August 15, 2014

    Report

    Report Number
    2025587-2014-00577
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 11, 2014
    Report Date
    September 5, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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. 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 INFORMATION AVAILABLE. A SECOND VALVE WAS IMPLANTED WHICH SUCCESSFULLY RESOLVED THE SEVERE REGURGITATION AND REDUCED IT TO MILD. MILD REGURGITATION HAS A MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    Additional Manufacturer Narrative · 1

    .

    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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AORTIC REGURGITATION WAS OBSERVED DUE TO A MODERATE-SEVERE PARAVALVULAR LEAK OBSERVED FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE, WHICH REDUCED THE LEAK TO MILD. NO ADDITIONAL INTERVENTION WAS PERFORMED. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489957 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention