BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3981020 · Received August 5, 2014

    Report

    Report Number
    2029214-2014-00444
    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 1: TREATMENT OF A LARGE UNRUPTURED WIDE NECK ANEURYSM MEASURING 12.7MM X 11.6MM LOCATED IN THE LEFT MCA (M1). THE PATIENT PRESENTED WITH AN UNRUPTURED MCA ANEURYSM THAT WAS DISCOVERED DURING A WORK-UP FOR SEVERE CERVICAL MYELOPATHY. THE PATIENT WAS GIVEN ASPIRIN AND CLOPIDOGREL TEN DAYS PRIOR TO THE PROCEDURE AND HEPARIN WAS ADMINISTERED INTRA-OPERATIVELY. THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE PROCEDURE, IT WAS REPORTED A PIPELINE (3MM X 16MM) WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM THAT EXTENDED FROM THE PROXIMAL SUPERIOR DIVISION OF THE M2 SEGMENT TO THE MIDDLE OF THE M1 SEGMENT WITHOUT ISSUES. POST PROCEDURAL ANGIOGRAM SHOWED STASIS WITHIN THE ANEURYSM. FIVE MONTHS POST PROCEDURE, THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) WITH AN ACUTE ONSET OF RIGHT SIDE HEMIPLEGIA. THE PATIENT HAD NOT BEEN COMPLIANT WITH THE ANTIPLATELET THERAPY. A NONCONTRAST HEAD CT (COMPUTED TOMOGRAPHY) SCAN DID NOT REVEAL A HEMORRHAGE; HOWEVER, A CT ANGIOGRAPHY REVEALED COMPLETE OCCLUSION OF THE M1 SEGMENT. THE PATIENT WAS TRANSFERRED TO THE ANGIOGRAPHY SUITE AND UNDERWENT MECHANICAL THROMBECTOMY. A LEFT ICA (INTERNAL CAROTID ARTERY) INJECTION SHOWED THE PIPELINE HAD MIGRATED DISTALLY WITH THE PROXIMAL END WITHIN THE ANEURYSM SACK, BUT THERE WAS NO EVIDENCE SHOWING THAT THE ANEURYSM WAS FILLING. A DECISION WAS MADE TO ABORT THE PROCEDURE SINCE BLIND NAVIGATION THROUGH THE ANEURYSM SAC MAY LEAD TO PERFORATION OF THE ANEURYSM. THE PATIENT REMAINED HEMIPLEGIC AND WAS DISCHARGED TO A REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456662 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77300-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention| S