BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS ENDOVASCULAR CORPORATION

    MDR report key: 1120303 · Received August 14, 2008

    Report

    Report Number
    2954740-2008-00003
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR ANALYSIS REVEALED THAT THE DETACHMENT FIBER DID NOT RECEIVE HEAT. POSSIBLY THE KNOTTING OF THE COIL IN THE ANEURYSM AND A QUICK SUDDEN REPOSITIONING, GIVEN THE LENGTH OF THE COIL MAY HAVE CONTRIBUTED TO THE UNINTENDED DETACHMENT.

    Description of Event or Problem · 1

    WHEN THE ANGIOGRAM SHOWED SOME OF THE ANEURYSM NOT COVERED WELL, THE PHYSICIAN REPOSITIONED THE COIL. AS HE WAS PULLING IT BACK, THE COIL DETACHED. PART OF THE COIL WAS IN THE ANEURYSM AND PART WAS IN THE CAROTID AND AORTA. TWO ATTEMPTS TO SNARE THE COIL WAS UNSUCCESSFUL. AT THIS POINT, AND AFTER A DISCUSSION WITH THE PATIENT'S FAMILY, THE PHYSICIAN DECIDED TO LEAVE THE COIL TO ENDOTHELIALIZE WITHIN THE ARTERY. THE PATIENT WAS PRESCRIBED WITH PLAVIX AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS ENDOVASCULAR CORPORATION EMBOLIC COIL HCG MICRUS ENDOVASCULAR CORPORATION PRESIDIO F38323

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention