BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 4960035 · Received August 3, 2015

    Report

    Report Number
    2025587-2015-00805
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 IMMEDIATELY FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM REVEALED MODERATE PARAVALVULAR LEAK (PVL) AND A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. AS THE BALLOON WAS BEING RETRIEVED, IT BECAME CAUGHT ON AN OUTFLOW STRUT AND DISLODGED THE VALVE FROM THE ANNULUS INTO THE ASCENDING AORTA. SEVERAL ATTEMPTS WERE MADE TO FREE THE BALLOON USING SNARES AND CATHETERS. ONE HOUR LATER, A DECISION WAS MADE TO CONVERT TO AN OPEN SURGICAL PROCEDURE AND THE VALVE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503583 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention