BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3050489 · Received April 10, 2013

    Report

    Report Number
    2029214-2013-00347
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PIPELINE, MARKSMAN CATHETER, AND PUSHWIRE WERE RETURNED FOR EVALUATION. THE PUSHWIRE WAS BROKEN INTO TWO SEGMENTS AND CROSS-SECTIONAL ANALYSIS OF THE BREAK POINTS INDICATED THAT THE FAILURE MODE WAS DUE TO TORSIONAL OVERLOAD.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED SUPRACLINOID SACCULAR ANEURYSM MEASURING 15MM X 6MM. DURING THE PIPELINE PROCEDURE INVOLVING FOUR PIPELINES. IT WAS REPORTED THAT THE FIRST PIPELINE MISSED THE LANDING ZONE AND WAS REMOVED FROM THE PATIENT. THE SECOND PIPELINE'S PUSHWIRE FRACTURED WHILE THE PHYSICIAN WAS TORQUING IT TO RELEASE THE PIPELINE FROM THE CAPTURE COIL. THE ENTIRE SYSTEM ALONG WITH THE BROKEN SEGMENT WAS REMOVED FROM THE PATIENT. THE THIRD PIPELINE WAS STUCK INSIDE THE CAPTURE COIL AND ALSO REMOVED FROM THE PATIENT. THE FOURTH PIPELINE WAS IMPLANTED SUCCESSFULLY. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148375 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71475-30 9690266

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR