BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3041550 · Received April 8, 2013

    Report

    Report Number
    2029214-2013-00340
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    TREATMENT OF AN UNRUPTURED OPHTHALMIC ICA (INTERNAL CAROTID ARTERY) ANEURYSM MEASURING 3MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OFF LABEL PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2013, WITH NO COMPLICATIONS; HOWEVER, THE PATIENT RETURNED THE NEXT DAY WITH RIGHT SIDED ARM WEAKNESS. A SCAN SHOWED A 3CM BLEED AT THE LEVEL OF THE ANEURYSM. IT WAS REPORTED THAT THE PATIENT STILL HAS RIGHT HEMIPARESIS AND APHASIA, BUT WILL RECOVER WITH REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142960 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-18 9681514

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability