BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROCOIL

    MDR report key: 3944481 · Received July 14, 2014

    Report

    Report Number
    MW5037274
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MICROVENTION
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS ENROLLED ON THE HEAT TRIAL, A MULTI-CENTER PROSPECTIVE ANEURYSM CLINICAL TRIAL, AND WAS RANDOMIZED TO THE HYDROCOIL EMBOLIC SYSTEM TREATMENT ARM. THE PT IS A (B)(6) FEMALE WHO PRESENTED WITH A RUPTURED ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (M1-M2 BIFURCATION). THE PT WAS COILED ON (B)(6) 2014 AND ON (B)(6) 2014, THE PT PRESENTED WITH A SUBARACHNOID HEMORRHAGE. DURING THE PROCEDURE, REOPRO WAS GIVEN BY IV BOLUS FOR BRANCH OCCLUSION AND STENTING OF M2 BRANCH. AN ANGIOGRAM SHOWED A MASSIVE INTRACEREBRAL HEMORRHAGE AT THE LEVEL OF THE LMCA WITH A HEMATOMA EXTENDING POSTERIOR AND MEDIAL. CTA DIDN'T SHOW ANY ACTIVE CONTRAST LEAK AT THE LEVEL OF THE LMCA. SIX HOURS POST PROCEDURE, THE PT PRESENTED WITH DILATED LEFT PUPIL AND RIGHT HEMIPLEGIA. PT WAS INTUBATED AND DIED ON (B)(6) 2014. SUBARACHNOID HEMORRHAGE WAS REPORTED AS A SERIOUS ADVERSE EVENT BECAUSE IT LED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409902 HYDROCOIL COIL HCG MICROVENTION 131007N4
    409903 HYDROFRAME COIL HCG MICROVENTION 13100319
    409904 HYDROFILL COIL HCG MICROVENTION 13072303

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death