BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3840961 · Received May 30, 2014

    Report

    Report Number
    2029214-2014-00307
    Event Type
    Death
    Date Received
    May 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPIRED FROM NATURAL CAUSES RELATING TO METASTATIC CANCER.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LARGE UNRUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 22MM X 6MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS (RELATED TO OPTIC NERVE PALSY) OF BLURRY VISION AND EYE PAIN. THE PATIENT WAS ON ANTICOAGULANTS / ANTIPLATELETS PRIOR TO THE PROCEDURE AND GIVEN HEPARIN INTRA-OPERATIVELY. ON (B)(6) 2012, THE PATIENT UNDERWENT PIPELINE (3.75MM X 14MM) EMBOLIZATION TREATMENT WITH A CONCOMITANT COILING PROCEDURE. POST PROCEDURAL IMAGING SHOWED SUCCESSFUL EMBOLIZATION OF THE ANEURYSM. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. IT WAS REPORTED THE PATENT EXPIRED LATER ON AN UNSPECIFIED DATE. THE CAUSALITY WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317849 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77375-14 9620524

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death