BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4708670 · Received April 20, 2015

    Report

    Report Number
    2029214-2015-00400
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    August 24, 2011
    Report Date
    March 23, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    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#. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE CITED THAT THREE PATIENTS EXPERIENCED SERIOUS ADVERSE EVENTS POST PIPELINE EMBOLIZATION DEVICE PLACEMENT PROCEDURES IN THEIR STUDY. THE AUTHORS REPORTED THAT SIXTY-THREE PATIENTS (52 FEMALE, 11 MALES), MEAN AGE 51 YEARS (27-75) WERE TREATED BETWEEN NOVEMBER 2008 AND FEBRUARY 2011. SEVENTY-ONE ENDOVASCULAR PROCEDURES FOR A TOTAL OF 73 INTRACRANIAL ANEURYSMS HAVE BEEN PERFORMED. ONE PATIENT WITH GIANT ANEURYSM HAD A SEVERE SUBARACHNOID HEMORRAGE AT 15 DAYS FROM THE PROCEDURE. TWO CASES SHOWED THE ASYMPTOMATIC INTERNAL CAROTID ARTERY OCCLUSION SEEN AT THE FIRST CONTROL; THE PERFORATING VESSELS HAVE BEEN SHOWED ALWAYS OPEN AT EACH CONTROL. NO MORE INFORMATION WILL BE AVAILABLE. 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
    260061 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability