BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROFRAM 10

    MDR report key: 3840807 · Received May 23, 2014

    Report

    Report Number
    MW5036353
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 22, 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) OLD MALE WHO PRESENTED WITH AN RUPTURED ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (M2). THE ANEURYSM WAS COILED ON (B)(6) 2014, A CT SCAN REVEALED A NEW HYPODENSITY IN THE RIGHT FRONTAL WHITE MATTER WHICH LIKELY REPRESENTS A NEW INFARCT. NO EVIDENCE OF HYDROCEPHALUS OR HEMORRHAGE WERE DEMONSTRATED. PT WAS PLACED ON DECADRON 4 MG IV EVERY 6 HOURS. UPON DISCHARGE ON (B)(6) 2014, THE PT WAS ALERT AND ORIENTED TO PERSON, PLACE, AND TIME. THE TRANSCRANIAL DOPPLERS WERE WITHIN NORMAL LIMITS. NO CRANIAL NERVE DEFICIT. THE PT EXHIBIT NORMAL MUSCLE TONE AND COORDINATION IS NORMAL. THE NEW INFARCT WAS REPORTED AS SERIOUS ADVERSE EVENT WHICH REQUIRED SUBJECT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307091 HYDROFRAM 10 NONE HCG MICROVENTION 13111215
    307092 HYDROFRAME NONE HCG MICROVENTION 131003H9
    307093 HYDROCOIL 10 NONE HCG MICROVENTION 130731H9

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention