BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3799198 · Received May 8, 2014

    Report

    Report Number
    2029214-2014-00259
    Event Type
    Death
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 02 JUN 2014 STATING THAT THE PATIENT SUFFERED AN INTRAPARENCHYMAL HEMORRHAGE 8 DAYS POST PROCEDURE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2014. 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 EVENT AS MDR#: 2029214-2014-00353. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT AS THE PIPELINE WAS FOUND RELEASED FROM THE CAPTURE COIL AND FULLY OPENED; HOWEVER, THE BRAID AND CAPTURE COIL WERE FOUND DAMAGED AND MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. (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 ZONED 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. NO PATIENT INJURY WAS REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277326 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-10 9653147

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death