BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6439243 · Received March 28, 2017

    Report

    Report Number
    2029214-2017-00236
    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 2029214-2017-00240 2029214-2017-00241 2029214-2017-00242 2029214-2017-00243 2029214-2017-00244.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION DURING LITERATURE REVIEW THAT THE PIPELINE FAILED TO EXPAND DURING EMBOLIZATION TREATMENT OF SMALL PARA OPHTHALMIC ANEURYSM. IT WAS REPORTED THAT THE PIPELINE WAS OPENED AND WELL APPOSED AT ITS DISTAL END IN THE SUPRACLINOID INTERNAL CAROTID ARTERY. HOWEVER, THE LARGER DIAMETER PIPELINE HAD DIFFICULTY IN OPENING AROUND THE POSTERIOR GENU AND FAILED TO FULLY EXPAND. THE DISTAL INTRACRANIAL CATHETER TECHNIQUE WAS THEN USED TO COMPLETE THE DEPLOYMENT OF THE PROXIMAL END. THE FINAL DEPLOYED PIPELINE WAS WELL APPOSED AND SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222960 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77450-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR