BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4668375 · Received April 8, 2015

    Report

    Report Number
    2029214-2015-00336
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    August 24, 2011
    Report Date
    March 23, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-011-0914-7?LI=TRUE#. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL REPORTED DEVICE MALFUNCTION EVENTS WERE CAPTURED IN THIS REPORT.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE THAT IN THREE PATIENTS THE PROCEDURE WAS STOPPED BEFORE THE STENT DETACHMENT DUE TO STRUCTURAL DAMAGE OF THE DEVICE IN THEIR STUDY. THE AUTHORS REPORTED THAT SIXTY-THREE PATIENTS (52 FEMALE, 11 MALES), MEAN AGE 51 YEARS (27-75) HAVE BEEN TREATED BETWEEN NOVEMBER 2008 AND FEBRUARY 2011. SEVENTY-ONE ENDOVASCULAR PROCEDURES FOR A TOTAL OF 73 INTRACRANIAL ANEURYSMS HAVE BEEN PERFORMED. THE PROCEDURE WAS ELECTIVE IN ALL PATIENTS EXCEPT 2 PRESENTED WITH SUBARACHNOID HEMORRHAGE AND TREATED IN EMERGENCY. DOUBLE ANTIPLATELET THERAPY (ASPIRIN 300 MG AND TYCLOPIDINE 250 MGX2) WAS DONE 5 DAYS BEFORE THE PROCEDURE; THE 2 PATIENTS TREATED ACUTELY ONLY RECEIVED CLOPIDOGREL LOADING DOSE OF 600 MG BEFORE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED DUE TO THE DAMAGE OF THE DEVICE. CITATION: A. PAOLUCCI, V. CIVELLI, R. PAPA, M. ISALBERTI. PRELIMINARY RESULTS IN 63 CONSECUTIVE PATIENTS TREATED FOR INTRACRANIAL ANEURYSMS USING FLOW-DIVERTING STENTS (PIPELINE EMBOLIZATION DEVICE. NEURORADIOLOGY (2011) 53 (SUPPL 1):S1-S71. (HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-011-0914-7?LI=TRUE#).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232867 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR