BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3980928 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00445
    Event Type
    Death
    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 2: TREATMENT OF A SMALL UNRUPTURED ANEURYSM MEASURING 2.8MM X 2.3MM WITH NO DISTINCT NECK LOCATED IN THE SUPRACLINOID SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH A GIANT LEFT SUPRACLINOID ICA ANEURYSM THAT WAS DISCOVERED ON MRA (MAGNETIC RESONANCE ANGIOGRAPHY) DURING A VISUAL FIELD TEST. THE VISUAL FIELD TEST REVEALED RIGHT SIDE HOMONYMOUS HEMIANOPSIA. THE PATIENT WAS GIVEN ASPIRIN AND PLAVIX PRIOR TO THE PROCEDURE. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE PROCEDURE, IT WAS REPORTED A PIPELINE (4.25MM X 30MM) WAS DEPLOYED FROM THE M1 SEGMENT TO THE PROXIMAL CAVERNOUS ICA. POST PROCEDURAL ANGIOGRAM SHOWED STASIS WITHIN THE ANEURYSM AND EXCELLENT FILLING OF THE CEREBRAL ARTERIES. THE PATIENT WAS NEUROLOGICALLY INTACT AFTER THE PROCEDURE. THREE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDE HEMIPLEGIA WITH SEVERE HEADACHES AND A NONCONTRAST CT (COMPUTED TOMOGRAPHY) SCAN REVEALED AN EXTENSIVE SAH (SUBARACHNOID HEMORRHAGE). THE PATIENT UNDERWENT ANTIPLATELET REVERSAL THERAPY AND A RIGHT FRONTAL VENTRICULOSTOMY WAS PLACED. DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) SHOWED THE PIPELINE HAD MIGRATED PROXIMALLY WITH THE DISTAL END OF THE PIPELINE FALLING INTO THE ANEURYSM SAC DIVERTING FLOW INTO THE DOME OF THE ANEURYSM AND RUPTURING IT. SEVERAL COILS WERE DEPLOYED INTO THE ANEURYSM AND THE PARENT ARTERY WAS DECONSTRUCTED TO PREVENT A NEW HEMORRHAGE. THE LEFT ICA WAS OCCLUDED WITH COILS AND ONYX 34. ANGIOGRAM SHOWED NO FILLING OF THE LEFT ICA ANEURYSM AFTER THE OCCLUSION; HOWEVER, THE PATIENT EXPERIENCED UNCONTROLLABLE INTRACRANIAL PRESSURE AND RAPIDLY PROGRESSED TO BRAIN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456516 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71425-30 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death