BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4869275 · Received June 25, 2015

    Report

    Report Number
    2029214-2015-00730
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OFF LABEL USE: PIPELINE EMBOLIZATION DEVICE (PED) IS CONTRAINDICATED IN PATIENTS IN WHOM A PRE-EXISTING STENT IS IN PLACE IN THE PARENT ARTERY AT THE TARGET ANEURYSM LOCATION. IN THIS STUDY, THE PED WAS USED IN AN OFF-LABEL MANNER IN A PATIENT WITH PRE-EXISTING NITINOL SELF-EXPANDING STENTS. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE DEVICE LOT NUMBER WAS NOT REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. SERIOUS ADVERSE EVENTS FROM THE SAME ARTICLE WAS REPORTED IN MDR MFR# 2029214-2015-00731. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT ONE PIPELINE EMBOLIZATION DEVICE (PED) WAS NOT SUCCESSFULLY DEPLOYED. A LARGE FUSIFORM ANEURYSM OF THE BASILAR ARTERY COULD NOT BE TREATED, BECAUSE DURING STENT DEPLOYMENT, THE PED BECAME CAUGHT IN THE STRUTS OF THE EXISTING STENT, WHICH PREVENTED PROPER DEPLOYMENT AND LED TO AN ABORTION OF THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS PROCEDURE. IN THIS ARTICLE, THE AUTHORS REPORTED THEIR EXPERIENCE USING FLOW-DIVERTING STENTS IN THE REPAIR OF 25 ANEURYSMS FOR WHICH STENT-ASSISTED EMBOLIZATION HAD FAILED. CITATION: HEIFERMAN DM, BILLINGSLEY JT, KASLIWAL MK, ET AL. USE OF FLOW-DIVERTING STENTS AS SALVAGE TREATMENT FOLLOWING FAILED STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSMS.J NEUROINTERV SURG. 2015 JUN 3. PII: NEURINTSURG-2015-011672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411429 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR