BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4358578 · Received December 23, 2014

    Report

    Report Number
    2029214-2014-00781
    Event Type
    Injury
    Date Received
    December 23, 2014
    Report Date
    December 2, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED.THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE PIPELINE WAS IMPLANTED IN THE PATIENT AND THE BROKEN DISTAL WIRE REMAINS IN THE PATIENT SECURED AGAINST THE VESSEL WALL BY THE IMPLANTED PIPELINE; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.(B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: LYLYK P, MIRANDA C, CERATTO R. CURATIVE ENDOVASCULAR RECONSTRUCTION OF CEREBRAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE: THE BUENOS AIRES EXPERIENCE. NEUROSURGERY. 2009: 64:632¿643. A STUDY WAS CONDUCTED WITH A SERIES OF 53 PATIENTS. ALL THE PATIENTS WERE HARBORING LARGE AND GIANT WIDE-NECKED, NON-SACCULAR, AND RECURRENT INTRACRANIAL ANEURYSMS. THE PATIENTS WERE GIVEN DUAL ANTIPLATELET THERAPY PRIOR TO THE PROCEDURES AND CONTINUED TO TAKE BOTH FOR AT LEAST SIX MONTHS AFTER THE PROCEDURES. NO MAJOR COMPLICATIONS (STROKE OR DEATH) OCCURRED DURING THE STUDY. IN ONE PROCEDURE, THE DISTAL TIP OF THE PIPELINE DELIVERY WIRE BECAME ENGAGED IN THE DEPLOYED PIPELINE AND FRACTURED. THE FRACTURED DISTAL ASPECT OF THE WIRE WAS SECURED INTO A STABLE POSITION AGAINST THE VESSEL WALL BY THE DEPLOYED PIPELINE. THIS COMPLICATION DID NOT RESULT IN A CLINICALLY EVIDENT COMPLICATION. THIS EVENT IS FROM THE SAME ARTICLE AS MDR# 2029214-2014-00782.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846564 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability