BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2980453 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00168
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    September 6, 2011
    Report Date
    February 8, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATING THE MDR WITH ADDITIONAL INFORMATION REGARDING THE PATIENT'S MEDICAL HISTORY ON (B)(4) 2013 STATING THAT THE PATIENT UNDERWENT PARENT VESSEL SACRIFICE OF THE LEFT ICA (INTERNAL CAROTID ARTERY) FOR A PROGRESSIVELY ENLARGING GIANT CAV (CAVERNOUS) ANEURYSM. (B)(4).

    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-71500-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. MODEL: FA-77500-12 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. REFERENCE (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED CAV (CAVERNOUS) ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 25MM X 14.3MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2011 INVOLVING FIVE TELESCOPING PIPELINES AND WAS PRESENTED WITH A RIGHT EYE DROOP AND 3RD NERVE PALSY APPROXIMATELY TEN MONTHS LATER. IT IS REPORTED THAT THE PATIENT'S CONDITION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84048 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71500-35 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability