BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3042392 · Received April 9, 2013

    Report

    Report Number
    2029214-2013-00338
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    TREATMENT OF A LEFT UNRUPTURED OPHTHALMIC SACCULAR ANEURYSM MEASURING 14.55MM X 7MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2013 INVOLVING TWO PIPELINES IN TORTUOUS ANATOMY. DUE TO THE TORTUOUS ANATOMY, THE FIRST PIPELINE COULD NOT BE DEPLOYED AS DISTALLY AS NEEDED. IT WAS DEPLOYED IN A SLIGHTLY STENOSED AREA AND REQUIRED BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) TO ACHIEVE FULL WALL APPOSITION. ANGIOGRAPHY SHOWED SOME JETTING INTO THE DISTAL ANEURYSM; THEREFORE, A SECOND PIPELINE WAS DEPLOYED AT THE NECK OF THE ANEURYSM. POST PROCEDURE, A DYNA CT SHOWED THAT THE PATIENT HAD AN SAH (SUBARACHNOID HEMORRHAGE) ON THE IPSILATERAL SIDE DUE TO THE PATIENT HAVING A PRU OF 95 BEFORE THE PROCEDURE. NO OTHER INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR # 2029214-2013-00339.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145092 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-20 9643939

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention