BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3000580 · Received March 12, 2013

    Report

    Report Number
    2029214-2013-00175
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    December 26, 2009
    Report Date
    February 18, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: FA-77350-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77425-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77475-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 5). MODEL: FA-77450-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77450-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 4). MODEL: FA-77475-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 4). MODEL: FA-77475-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2). MODEL: FA-77500-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 4). MODEL: FA-77400-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77450-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2). MODEL: FA-77425-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77500-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2). MODEL: FA-77400-18 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPID CLINICAL DATABASE. TREATMENT OF A LEFT AND RIGHT UNRUPTURED FUSIFORM ICA (INTERNAL CAROTID ARTERY) OTHER CAVERNOUS ANEURYSM MEASURING 20MM X 50MM AND 16MM X 36MM RESPECTIVELY. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2009 INVOLVING 15 PIPELINES AND AGAIN ON (B)(6) 2009 INVOLVING 14 PIPELINES. THE PATIENT EXPERIENCED LEFT HEMIPARESIS ON (B)(6) 2009 DUE TO A MALIGNANT MCA (MIDDLE CEREBRAL ARTERY) OCCLUSION AND REQUIRED DECOMPRESSING CRANIOTOMY. CLOPIDOGREL WAS STOPPED FIVE MONTHS AFTER THE TREATMENT OF THE RIGHT ICA AND TWO MONTHS AFTER TREATMENT OF LEFT ICA. BOTH ICAS OCCLUDED SIMULTANEOUSLY. RIGHT HEMIPARESIS AND APHASIA BECAME PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104166 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Disability