BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3137813 · Received May 30, 2013

    Report

    Report Number
    2029214-2013-00527
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION ON (B)(4) 2013 REGARDING THE ANEURYSM SIZE AND PATIENT CONDITION. THE ANEURYSM WAS SACCULAR MEASURING 11MM WITH A 6MM NECK AND THE PATIENT CONDITION WAS NORMAL. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    DURING THE PIPELINE PROCEDURE INVOLVING TWO PIPELINES, IT WAS REPORTED THAT BOTH PIPELINES COULD NOT BE OPENED DISTALLY AND THE PROXIMAL SEGMENTS WERE PINCHED LOSING WIRE ACCESS. A WIRE WAS USED TO GAIN ACCESS AND ANGIOPLASTY WITH A HYPERFORM BALLOON WAS PERFORMED (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) TO OPEN THE DEVICES AND ACHIEVE FULL WALL APPOSITION. SAME EVENT AS MDR# 202921-2013-00528. IT WAS REPORTED THAT THE PATIENT HAD SLIGHT RIGHT ARM WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239074 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-20 AP12-028

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention