BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2981270 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00170
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    June 24, 2009
    Report Date
    February 13, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL: FA-77350-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A MIDLINE UNRUPTURED BASILAR SIDEWALL FUSIFORM ANEURYSM MEASURING 11.6MM X 10.9MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION INVOLVING 2 TELESCOPING PIPELINES ON (B)(6) 2009 AND EXPERIENCED HEADACHES, NAUSEA, AND VOMITING FOUR DAYS POST PROCEDURE. THE PATIENT WAS DISCHARGED WITH TAPERING DOSES OF DECADRON AND IBUPROFEN. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83726 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Disability