BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORFLEX DELIVERY SYSTEM

    MDR report key: 4540954 · Received February 13, 2015

    Report

    Report Number
    MW5040847
    Event Type
    Injury
    Date Received
    February 13, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 13, 2015
    Manufacturer
    LOMBARD MEDICAL
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NOSE CONE OF THE AORFLEX DELIVERY DEVICE BECAME DISLODGED WITHIN THE ANEURYSM DURING PROCEDURE. ATTEMPTS TO RETRIEVE THE DETACHED PORTION WERE UNSUCCESSFUL AND FOLLOWING VASCULAR SURGERY CONSULTATION, THE NOSE CONE WAS SECURED AGAINST THE ARTERY WALL BY ADD'L INSERTION OF AN ENDOVASCULAR EXTENSION AND COVERED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108320 AORFLEX DELIVERY SYSTEM SYSTEM, ENDOVASCULAR STENT GRAFT MIH LOMBARD MEDICAL BK52445-1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention