BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4492403 · Received February 6, 2015

    Report

    Report Number
    2029214-2015-00102
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    February 18, 2014
    Report Date
    January 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-014-1339-X. THE AUTHOR REPORTED OFF-LABEL USE OF PIPELINE EMBOLIZATION DEVICE (PED) FOR TREATMENT OF LARGE AND COMPLEX MIDDLE CEREBRAL ARTERY (MCA) ANEURYSMS. 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 AND FOLLOW UP IS NOT POSSIBLE FROM THIS LITERATURE, THEREFORE ALL THREE SERIOUS ADVERSE EVENTS WERE CAPTURED IN (B)(4).

    Description of Event or Problem · 1

    ARTICLE/LITERATURE: ZANATYM, CHALOUHI N, TJOUMAKARIS SI, ET AL. FLOW DIVERSION FOR COMPLEX MIDDLE CEREBRAL ARTERY ANEURYSM. NEURORADIOLOGY. 2014. 56:381-387. COVIDIEN RECEIVED THE FOLLOWING THROUGH A REVIEW OF LITERATURE. THE AUTHOR REPORTED OFF-LABEL USE OF PIPELINE EMBOLIZATION DEVICE (PED) FOR TREATMENT OF LARGE AND COMPLEX MIDDLE CEREBRAL ARTERY (MCA) ANEURYSMS. THIS EVENT WAS OPEN TO CAPTURE THREE ADVERSE EVENTS REPORTED IN THIS ARTICLE: ONE PATIENT HAD A PERIPROCEDURAL COMPLICATION; THE PED TREATMENT WAS UNEVENTFUL BUT ANTIPLATELET DRUGS HAD TO BE STOPPED BEFORE COLONOSCOPY AND THE PATIENT DEVELOPED A RIGHT MCA STROKE. ANTIPLATELET THERAPY WAS THEN RESUMED AND THE PATIENT RAPIDLY IMPROVED, MRS AT DISCHARGE=1. ONE PATIENT STOPPED HIS ANTIPLATELET DRUGS (APD) AGAINST MEDICAL ADVICE AND DEVELOPED A COMPLETE SPHENOIDAL SEGMENT (M1) MIDDLE CEREBRAL ARTERY OCCLUSION WITH THE LENTICULOSTRIATE ARTERIES. A (B)(6) YEAR OLD MALE PATIENT WITH A RIGHT-SIDED DISSECTING M3 ANEURYSM AND WAS TREATED BY EMBOLIZATION WITH PED. SIX MONTH FOLLOW-UP SHOWED A COMPLETE OCCLUSION OF HIS DISEASED M3 VESSEL ON HIS LATEST FOLLOW-UP AT SIX MONTHS AFTER THE PROCEDURE BUT WAS COMPLETELY ASYMPTOMATIC. ABSTRACT. INTRODUCTION: THIS STUDY AIMS TO EVALUATE THE SAFETY AND EFFICACY OF FLOW DIVERSION FOR TREATMENT OF LARGE AND COMPLEX MIDDLE CEREBRAL ARTERY (MCA) ANEURYSMS. METHODS: WE CONDUCTED A RETROSPECTIVE REVIEW OF THE CLINICAL CHARTS OF ALL PATIENTS WHO UNDERWENT PIPELINE EMBOLIZATION DEVICE (PED) PLACEMENT FOR ANEURYSM AT OUR INSTITUTION FROM OCTOBER 2010 TO OCTOBER 2013. WE INCLUDED TEN PATIENTS, OF WHICH FIVE HAD LARGE MCA ANEURYSMS AND THREE HAD GIANT ONES. FUSIFORM UNRUPTURED ANEURYSMS REPRESENTED SEVEN OF ALL TEN ANEURYSMS. ANGIOGRAPHIC AND CLINICAL FOLLOW-UP WERE AVAILABLE FOR ALL PATIENTS MOSTLY BETWEEN 7 AND 12 MONTHS. RESULTS: WE HAD NO TECHNICAL COMPLICATIONS, ONE PERIPROCEDURAL MORBIDITY, AND NO MORTALITY. ON FOLLOW-UP, WE HAD NO HEMORRHAGIC COMPLICATIONS, NO ANEURYSMS RUPTURE, AND ONLY ONE CLINICALLY SIGNIFICANT THROMBOEMBOLIC EVENT IN A PATIENT WHO DISCONTINUED ANTIPLATELET THERAPY AGAINST MEDICAL ADVICE. ONE PATIENT HAD COMPLETELY OCCLUDED HIS DISEASED VESSEL BUT REMAINED ASYMPTOMATIC. THE OVERALL COMPLICATION RATE IS 3/10. ON FOLLOW-UP, COMPLETE OCCLUSION OCCURRED IN SEVEN PATIENTS (7/9). CONCLUSION: PED TREATMENT FOR LARGE, GIANT, AND BIFURCATION MCA ANEURYSMS WAS FEASIBLE, WITH SATISFYING COMPLETE OCCLUSION RATE, NO MORTALITY, AND REASONABLE MORBIDITY RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88051 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability