BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3980772 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00446
    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 3: TREATMENT OF A SMALL ANEURYSM MEASURING 6.43MM X 6.97MM X 3.36MM LOCATED IN THE SUPERIOR HYPOPHYSEAL SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY) AND A SMALL ANEURYSM MEASURING 2.97MM X 3.63MM X 3MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA. THE PATIENT PRESENTED WITH 2 ANEURYSMS THAT WERE INCIDENTALLY DISCOVERED. THE PATIENT WAS PRESCRIBED ASPIRIN AND CLOPIDOGREL. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE PROCEDURE, A PIPELINE (4MM X 25MM) WAS DEPLOYED ACROSS THE TWO ANEURYSMS USING THE TRI-AXIAL SYSTEM WITHOUT DIFFICULTY. THE PIPELINE EXTENDED FROM THE PARACLINOID SEGMENT OF THE ICA TO THE PETROUS SEGMENT. CONTROL ANGIOGRAPHY DEMONSTRATED ADEQUATE PIPELINE PLACEMENT AND CONTRAST STASIS IN THE SUPERIOR HYPOPHYSEAL SEGMENT ANEURYSM. DYNACT DEMONSTRATED ADEQUATE PIPELINE APPOSITION TO THE VESSEL WALL AND THE NECKS OF BOTH ANEURYSMS WERE COVERED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO ISSUES. A FOLLOW-UP ANGIOGRAPHY FOUR MONTHS POST PROCEDURE REVEALED THE DISTAL PORTION OF THE PIPELINE HAD MIGRATED SLIGHTLY PROXIMAL WITH THE NECK OF THE SUPERIOR HYPOPHYSEAL ANEURYSM NO LONGER COVERED BY THE PIPELINE. THERE WAS COMPLETE FILLING OF SUPERIOR HYPOPHYSEAL SEGMENT ANEURYSM, AND THE CAVERNOUS SEGMENT ANEURYSM WAS COMPLETELY RESOLVED. THE PATIENT WAS RESCHEDULED FOR A SUBSEQUENT EMBOLIZATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458272 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71400-25 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Disability