BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6439278 · Received March 28, 2017

    Report

    Report Number
    2029214-2017-00240
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    June 8, 2015
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LI-MEI LIN,1 GEOFFREY P COLBY,2 BOWEN JIANG ET. AL INTRA-DIC (DISTAL INTRACRANIAL CATHETER) DEPLOYMENT OF THE PIPELINE EMBOLIZATION DEVICE: A NOVEL RESCUE STRATEGY FOR FAILED DEVICE EXPANSION. J NEUROINTERVENT SURG 2015;0:1¿7. DOI:10.1136/NEURINTSURG-2015-011771 1 THE PIPELINE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE AUTHOR OF THE ARTICLE. MDRS RELATED TO THIS EVENT: 2029214-2017-00234, 2029214-2017-00235, 2029214-2017-00236, 2029214-2017-00237, 2029214-2017-00238, 2029214-2017-00239, 2029214-2017-00241, 2029214-2017-00242, 2029214-2017-00243 AND 2029214-2017-00244. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION DURING LITERATURE REVIEW THAT DURING EMBOLIZATION TREATMENT OF SMALL OPHTHALMIC, PERIOPHTHALMIC ANEURYSM, THE MIDDLE SEGMENT OF PIPELINE EMBOLIZATION DEVICE WAS NOT FULLY OPEN. IT WAS REPORTED THAT PIPELINE WAS FAILED TO OPEN AND RESULTED IN AN INCOMPLETELY EXPANDED AND STRETCHED THE DEVICE. BALLOON WAS USED TO FULLY OPEN THE PIPELINE. THE PATIENT WAS TREATED WITH ONLY ONE PED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223429 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77375-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR