BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4101455 · Received August 27, 2014

    Report

    Report Number
    2029214-2014-00499
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVAL AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES. THE PT'S ANATOMY WAS MINOR IN TORTUOSITY. DURING THE PROCEDURE, IT WAS REPORTED THAT BOTH PIPELINES (5MM X 16MM; 5MM X 12MM) SUCCESSFULLY DETACHED FROM THE CAPTURE COIL; HOWEVER, THEY WOULD NOT COMPLETELY OPEN DESPITE PUSHING AND WAGGING THE PUSHWIRE FROM THE INNER CURVE TO THE OUTER CURVE MULTIPLE TIMES. THE PIPELINES DID NOT APPEAR TWISTED IN EITHER OF THE BIPLANE VIEWS. BOTH PIPELINES WERE REMOVED FROM THE PT BY TRAPPING THE PIPELINE BRAID BETWEEN THE CAPTURE COIL AND CATHETER. NO PT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00498.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519130 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION, PRODUCT CODE: OUT OUT EV3 NEUROVASCULAR FA-77500-12 9872888

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention