BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3980734 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00447
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 ARTICLE: CHALOUHI N, TJOUMAKARIS LF, GONZALEZ D, ET AL. SPONTANEOUS DELAYED MIGRATION / SHORTENING OF THE PIPELINE EMBOLIZATION DEVICE: REPORT OF 5 CASES. AM J NEURORADIOL. 2013 DEC; 34(12):2326-30. A TOTAL OF 155 PATIENTS WERE TREATED WITH PEDS (PIPELINE EMBOLIZATION DEVICE) AT THOMAS JEFFERSON UNIVERSITY AND JEFFERSON HOSPITAL. OUT OF THE 155 PATIENTS, FIVE PATIENTS WERE DISCOVERED TO HAVE SPONTANEOUS DELAYED MIGRATION / SHORTENING OF THEIR PEDS DURING THEIR FOLLOW-UP ANGIOGRAPHY. THE PED WAS OBSERVED TO HAVE MIGRATED PROXIMALLY IN FOUR OF THE PATIENTS, WHILE MIGRATING DISTALLY IN ONE. OUT OF THESE FIVE PATIENTS, ONE PATIENT EXPIRED DUE TO AN SAH (SUBARACHNOID HEMORRHAGE) CAUSED BY THE MIGRATION OF THE PED AND ONE PATIENT PRESENTED WITH A COMPLETED OCCLUSION OF THE MCA (MIDDLE CEREBRAL ARTERY) LEAVING THEM SEVERELY DISABLED. CASE 4: TREATMENT OF A LARGE ANEURYSM (EXACT SIZE UNKNOWN) LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH RETRO-ORBITAL PAIN. THE PATIENT UNDERWENT AN UNEVENTFUL PIPELINE EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. FIVE MONTHS POST PROCEDURE, THE PATIENT'S SYMPTOMS RETURNED AND FOLLOW-UP ANGIOGRAM A MONTH LATER REVEALED THE PIPELINE HAD MIGRATED AND THE DISTAL END OF THE DEVICE WAS PROJECTING DIRECTLY INTO THE ANEURYSM SAC. A SECOND PIPELINE WAS IMPLANTED WITHIN THE PREVIOUSLY IMPLANTED PIPELINE TO ENSURE FULL COVERAGE OF THE ANEURYSM NECK. SIX WEEKS LATER, THE SYMPTOMS HAD COMPLETELY RESOLVED. CT (COMPUTED TOMOGRAPHY) SHOWED COMPLETE OBLITERATION OF THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457808 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S