BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 4466434 · Received January 22, 2015

    Report

    Report Number
    MW5040475
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 22, 2015
    Manufacturer
    MEDTRONIC COREVALVE LLC.
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING TAVR WITH 31 MM COREVALVE. THE DISTAL CONE OF THE DELIVERY SYSTEM FRACTURED WITH EMBOLIZATION INTO THE LEFT INTERNAL ILIAC ARTERY. ATTEMPTS TO SNARE THE NOSE CONE WERE UNSUCCESSFUL AS WAS BALLOON PLACEMENT WITH REMOVAL THROUGH THE SHEATH, AND REPEATED SNARE REMOVAL. THE NOSE CONE THEN FELL INTO THE LEFT INTERNAL ILIAC SYSTEM AND LODGED THERE BY FLOW. THERE WAS NO EVIDENCE OF THROMBOSIS, DISSECTION OR PERFORATION, AND THE DECISION WAS MADE TO LEAVE THE NOSE CONE SAFELY IN THE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53010 MEDTRONIC TRANSCATHETER AORTIC VALVE DELIVERY CATHETER SYSTEM COMPRESSION LOADING SYSTEM NPT MEDTRONIC COREVALVE LLC. MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other