BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3645863 · Received February 25, 2014

    Report

    Report Number
    2029214-2014-00086
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    November 18, 2013
    Report Date
    January 27, 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 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

    INFORMATION RECEIVED FROM THE (B)(6). TREATMENT OF A LARGE UNRUPTURED IRREGULAR LOBULATED SIDEWALL ANEURYSM MEASURING 10.8MM X 6.3MM LOCATED IN THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS OF DIZZINESS OR LOSS OF BALANCE AND COORDINATION. THE BASELINE MRS (MODIFIED RANKIN SCALE) = 0 (NO SYMPTOMS). ON (B)(6) 2013, THE PATIENT UNDERWENT PIPELINE (4.00MM X 20MM) EMBOLIZATION TREATMENT. THE PATIENT WAS ON ANTIPLATELET THERAPY PRIOR TO THE PROCEDURE AND WAS GIVE HEPARIN INTRA-OPERATIVELY. AFTER PIPELINE PLACEMENT, THE MRS = 1 (NO SIGNIFICANT DISABILITY, ABLE TO CARRY OUT ALL USUAL ACTIVITIES, DESPITE SOME SYMPTOMS). THE SCALE OF ROY AND RAYMOND = COMPLETELY OCCLUDED. ON THE SAME DAY POST PROCEDURE, THE PATIENT EXPERIENCED MODERATE, NON-SERIOUS, ADVERSE EVENTS OF DIPLOPIA, RIGHT EYE PTOSIS, AND MILD RIGHT 3RD NERVE PALSY. THE ADVERSE EVENT WAS NOTED AS PROCEDURE RELATED AND RESOLVED ON (B)(6) 2013. MEDICATION WAS GIVEN, BUT THE TYPE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116299 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention