BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 4603986 · Received March 6, 2015

    Report

    Report Number
    MW5041397
    Event Type
    Other
    Date Received
    March 6, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 6, 2015
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF THE TAVR, THE COREVALVE DEPLOYED IN A SUB-OPTIMAL POSITION. WHILE ATTEMPTING TO RETRIEVE THE COREVALVE INTO THE DELIVERY SHEATH FOR REDEPLOYMENT, THE DEVICE WOULD NOT COME THROUGH THE SHEATH. THE DELIVERY SYSTEM WAS THEN BEING REMOVED AND IT APPEARED THAT THE NOSE CONE HAD SHEARED OFF THE DISTAL END OF THE DELIVERY SYSTEM. ATTEMPTS WERE MADE TO SNARE THE NOSE CONE WERE UNSUCCESSFUL. IT MIGRATED AND LODGED INTO THE RIGHT INTERNAL ILIAC ARTERY. REPEAT ANGIOGRAPHY REVEALED FLOW IN THE RIGHT INTERNAL ILIAC ARTERY AND THE NOSECONE WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156218 MEDTRONIC TRANSCATHETER AORTIC VALVE DELIVERY CATHETER SYSTEM NPT MEDTRONIC COREVALVE LLC DCS-C4-18F-US 0007307040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other