BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4513757 · Received February 12, 2015

    Report

    Report Number
    2029214-2015-00127
    Event Type
    Malfunction
    Date Received
    February 12, 2015
    Date of Event
    August 21, 2014
    Report Date
    January 13, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL DEVICE MALFUNCTION EVENTS WERE CAPTURED IN THIS REPORT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHORS. REFERENCE: (B)(4). SERIOUS INJURY EVENTS FROM THIS LITERATURE WAS REPORTED IN MFR# 2029214-2015-00120

    Description of Event or Problem · 1

    CITATION: TANWEER ET AL. CAVERNOUS CAROTID ANEURYSMS IN THE ERA OF FLOW DIVERSION: A NEED TO REVISIT TREATMENT PARADIGMS. AM J NEURORADIOL 35:2334-40. COVIDIEN RECEIVED INFORMATION THROUGH LITERATURE REVIEW AND THE FOLLOWING EVENTS WERE CAPTURED AS A RESULT OF THIS REVIEW: 41 PATIENTS WITH A CCA WERE TREATED WITH A PED (MEAN AGE 57, 36 FEMALES, MEAN RADIOGRAPHIC FOLLOW-UP WAS 2Y). IT WAS REPORTED THAT MOST INSTANCES OF BALLOON ANGIOPLASTY WAS TO APPOSE THE PED AGAINST THE VESSEL WALL IN CASES IN WHICH INCOMPLETE DEVICE OPENING WAS NOTED, ESPECIALLY IN CASES OF EXCESSIVELY TORTUOUS ANATOMY. NO INSTANCE OF VESSEL INJURY, DISSECTION OR RUPTURE WAS EXPERIENCED DURING OR AFTER BALLOON ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105435 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR