BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3033009 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00312
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE AND THE PIPELINE WERE RETURNED FOR EVALUATION SEPARATED. THE BRAIDS ON THE PIPELINE WERE FOUND TO BE DAMAGED ALONG WITH CLOTTED BLOOD WHICH LIKELY PREVENTED THE PIPELINE FROM FULLY OPENING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED CAV (CAVERNOUS) ANEURYSM MEASURING 19MM X 7MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES. THE FIRST PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL AND IT WAS REMOVED FROM THE PATIENT. THE SECOND PIPELINE RELEASED FROM THE CAPTURE COIL; HOWEVER, THE PROXIMAL END WOULD NOT OPEN. AFTER SEVERAL FAILED ATTEMPTS TO OPEN THE PROXIMAL END, THE PIPELINE WAS REMOVED FROM THE PATIENT WITH A SNARE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00311.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136161 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-18 9694816

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention