BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION PROCEDURE

    MDR report key: 2902202 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00012
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    May 21, 2011
    Report Date
    December 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE.TREATMENT OF A LEFT UNRUPTURED INTERNAL CEREBRAL ARTERY ANEURYSM MEASURING 8.5MM X 3.10MM. POST COILING WITH PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT AWAKENED WITH A MODERATELY SEVERE HEADACHE.NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE AND HER CONDITION RESOLVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9565 PIPELINE EMBOLIZATION PROCEDURE FLOW DIVERSION HCG EV3 NEUROVASCULAR FA-77475-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability