BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3090460 · Received May 2, 2013

    Report

    Report Number
    2029214-2013-00404
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL BROKEN SEGMENT OF THE PUSHWIRE WAS RETURNED FOR EVALUATION AND CROSS SECTIONAL ANALYSIS OF THE BREAK POINT INDICATED THAT THE FAILURE OF THE PUSHWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. PUSHWIRE SEPARATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT ICA (INTERNAL CAROTID ARTERY) MULTI LOBED, WIDE NECKED ANEURYSM MEASURING 10MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE STENT WAS CORKED AND PULLED PROXIMALLY BECAUSE IT WAS DEPLOYED 4MM TOO DISTAL OF THE ANEURYSM. THE PIPELINE WAS MOVED PROXIMALLY TO THE DESIRED AREA, BUT THE DISTAL PUSHWIRE WITH CAPTURE COIL FRACTURED WHEN THE PHYSICIAN ATTEMPTED TO UNCORK IT AND ADVANCE THE PUSHWIRE. THE PIPELINE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT; HOWEVER, THE BROKEN DISTAL PUSHWIRE WITH CAPTURE COIL MIGRATED TO THE ICA (INTERNAL CAROTID ARTERY) TERMINUS. AFTER SOME FAILED ATTEMPTS TO SNARE THE DISTAL BROKEN PUSHWIRE SEGMENT, A DECISION WAS MADE TO PIN THE BROKEN SEGMENT TO THE VESSEL WALL WITH ANOTHER PIPELINE WITH ONLY 5-10MM OF THE TIP COIL UNCOVERED BY THE PIPELINE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193156 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77375-14 9657815

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention| S