BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3864210 · Received June 10, 2014

    Report

    Report Number
    2029214-2014-00331
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    May 15, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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)(4). TREATMENT OF A LARGE UNRUPTURED SACCULAR ANEURYSM MEASURING 17MM X 10.6MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS OF EYE PAIN, HEADACHE, NAUSEA AND VOMITING, WHICH WERE RELATED TO OCULOMOTOR NERVE PALSY. THE PATIENT WAS GIVEN PLAVIX AND ASPIRIN PRIOR TO THE PROCEDURE AND WAS GIVEN HEPARIN INTRA-OPERATIVELY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (3.50MM X 25MM) EMBOLIZATION TREATMENTS. DURING THE PROCEDURE, CONTROL ANGIOGRAPHY REVEALED POOR APPOSITION OF THE PIPELINE SO BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) WAS PERFORMED TO ACHIEVE FULL WALL APPOSITION. POST PROCEDURAL IMAGING SHOWED COMPLETE OCCLUSION AND PIPELINE WITH GOOD APPOSITION TO THE PARENT VESSEL. THERE WAS NO ASSOCIATED THROMBUS, FLOW-LIMITING STENOSIS, OR EVIDENCE OF BRANCH VESSEL OCCLUSION. NO ADDITIONAL TREATMENT WAS NEEDED AND NO ADVERSE EVENTS WERE ASSOCIATED WITH THIS DEVICE MALFUNCTION. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED. ON FOLLOW-UP VISIT ON (B)(6) 2014, IMPROVEMENT IN INITIAL SYMPTOMS WERE SEEN AND THE PATIENT DID NOT EXHIBIT ANY NEW SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337841 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71350-25 9796120

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention