BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFILL

    MDR report key: 2994399 · Received February 28, 2013

    Report

    Report Number
    MW5029253
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 18, 2012
    Report Date
    February 28, 2013
    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 (B)(4) CLINICAL TRIAL AND WAS RANDOMIZED TO THE HYDROCOIL EMBOLIC SYS TREATMENT ARM. AT ENROLLMENT, THE RUPTURED, IRREGULAR, BIFURCATION ANEURYSM WAS LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY M2. DURING THE 3-28 DAY F/U, THE PT PRESENTED WITH FLUCTUATING APHASIA AND WAS TREATED FOR VASOSPASM AN ANTICIPATED ADVERSE EVENT WHICH VERAPAMIL ON (B)(6) 2012. PT WAS ADMITTED ON (B)(6) 2012 FOR THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2012. DATES OF USE: (B)(6) 2012 - (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87321 HYDROFILL HYDROFILL HCG MICROVENTION 120814H3
    87322 HYDROFRAME HYDROFRAME HCG MICROVENTION 12
    87412 HYDROFRAME 10 HYDROFRAME 10 HCG MICROVENTION 11012415
    87413 HYDROCOIL HYDROCOIL HCG MICROVENTION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention