BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3020002 · Received March 25, 2013

    Report

    Report Number
    2029214-2013-00281
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    January 5, 2012
    Report Date
    March 7, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE.TREATMENT OF A LEFT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 3MM X 1MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2012 AND EXPERIENCED RIGHT HAND NUMBNESS, TINGLING, AND FLOATERS IN VISION DURING A FOLLOW-UP VISIT ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122844 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability