BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROSOFT 10-SYSTEM COIL (HES)

    MDR report key: 1353805 · Received March 27, 2009

    Report

    Report Number
    2032493-2009-00017
    Event Type
    Injury
    Date Received
    March 27, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 27, 2009
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 12. COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AS IT IS IMPLANTED WITHIN THE PATIENT. ACCESSORY EQUIPMENT USED DURING THIS EMBOLIZATION PROCEDURE, CONSISTED OF A VISTA BRITE TIP GUIDING CATHETER MANUFACTURED BY CORDIS CORP., A SL 10 MICROCATHETER, SYNCHRO 2 GUIDEWIRE, AND A SYNCHRO 14 GUIDEWIRE MANUFACTURED BY BOSTON SCIENTIFIC, A HYPERFORM OCCLUSION BALLOON SYSTEM, A SILVERSPEED 15 GUIDEWIRE, AND AN X-PEDION GUIDEWIRE MANUFACTURED BY EV3 NEUROVASCULAR. THE EMBOLIZATION PROCEDURE LASTED FOR 5.5 HOURS. IT IS UNLIKELY THAT THE MRI INFARCTS RESULTED FROM EMBOLI GENERATED FROM THE MICROVENTION EMBOLIZATION COILS. THIS IS BECAUSE SOME OF THE MRI INFARCT AREAS WERE SERVED BY ARTERIAL BRANCHES THAT WERE PROXIMAL (RETROGRADE) TO THE ANEURYSM IN WHICH MICROVENTION EMBOLIZATION COILS WERE DEPLOYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTING WITH HEMIPLEGIA ASSOCIATED WITH PRIOR CEREBRAL ANEURYSM RUPTURE, INCURRED SMALL CEREBRAL INFARCTS VISUALIZED BY MRI, AND A HEADACHE, AFTER RETREATMENT OF AN UNRUPTURED POSTERIOR COMMUNICATING (PCOM) ANEURYSM USING MICROVENTION EMBOLIZATION COILS. THE HEADACHE RESOLVED AFTER ADMINISTRATION OF DECADRON, A GLUCOCORTICOSTEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSOFT 10-SYSTEM COIL (HES) DEVICE 2 OF 12 - EMBOLIZATION COIL HCG MICROVENTION, INC. 100203H2HS-V P0811184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S