BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4092374 · Received September 4, 2014

    Report

    Report Number
    2029214-2014-00517
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 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 EVALUATION AS IT WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM LOCATED IN THE RIGHT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PROXIMAL END OF THE PIPELINE (3.25MM X 16MM) COULD NOT BE OPENED DESPITE MANIPULATION. THE PIPELINE WAS OPENED WITH THE AID OF A BALLOON (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, US). BY ACCESSING IT THROUGH THE TRANS A-COMM (ANTERIOR COMMUNICATING) ARTERY. SUBSEQUENTLY THE PATIENT HAD A SMALL BLEED DUE TO THE TRANS A-COMM APPROACH AFTER THE PIPELINE WAS IMPLANTED. THE PATIENT SUFFERED A RIGHT HEMISPHERIC STROKE AS A RESULT OF THE DEVICE NOT OPENING CORRECTLY. THE PATIENT WAS HOSPITALIZED AND INTUBATED POST PROCEDURE. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT WAS STILL IN THE HOSPITAL AND HEMIPLEGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541470 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77325-16 9868820

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R| S