BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3903058 · Received June 30, 2014

    Report

    Report Number
    2029214-2014-00353
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    April 19, 2014
    Report Date
    June 2, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT HAVE NOT BEEN RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL#: NOT REPORTED / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A (QTY. 2). (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SMALL ANEURYSM MEASURING (8MM X 6MM) LOCATED IN THE OPHTHALMIC SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DUE TO THE CHALLENGING DISTAL LANDING ZONE THAT HAD A WIDER TO SMALLER SHAPE, THREE PIPELINES WERE TO BE IMPLANTED IN THE PATIENT. AFTER SUCCESSFUL PLACEMENT OF THE FIRST TWO PIPELINES, THE THIRD PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL AND IT WAS PULLED INTO THE MARKSMAN AND THE ENTIRE SYSTEM WAS RETRIEVED FROM THE PATIENT. THE PATIENT WAS SUCCESSFULLY TREATED WITH ANOTHER PIPELINE (5.00MM X 12MM) IN ORDER TO SEAL THE PROXIMAL END OF THE PIPELINE CONSTRUCT. POST PROCEDURAL IMAGING WAS FINE AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT EXPERIENCED A DISTAL INTRAPARENCHYMAL HEMORRHAGE 8 DAYS POST PROCEDURE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2014. THE CAUSE OF THE HEMORRHAGE WAS UNKNOWN. THE BLEED WAS ON THE SAME SIDE AS THE PROCEDURE; HOWEVER, THE LOCATION OF THE BLEED WAS MORE DISTAL TO WHERE THE PROCEDURE WAS PERFORMED. SAME PATIENT AS MDR # 2029214-2014-00259.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381147 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-12 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death