BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5693120 · Received June 1, 2016

    Report

    Report Number
    2029214-2016-00358
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    January 22, 2016
    Report Date
    May 25, 2016
    Manufacturer
    MEDTRONIC NEUROVASCULAR
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC4819826/ DUE TO THE NATURE OF THIS STUDY (META ANALYSIS), THIS REPORT MAY BE A DUPLICATE OF A PREVIOUSLY REPORTED ADVERSE EVENTS. 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. THE CAUSE OF ADVERSE EVENTS WERE NOT REPORTED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. SAME ARTICLE AS REPORTED IN MDR MFR: 2029214-2016-00359.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE REVIEW THAT PROCEDURE-RELATED THESE ADVERSE EVENTS OCCURRED IN FLOW DIVERTER (FD) TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS (PCAS) ISCHEMIC STROKE RATE WAS 11 %. PERFORATOR INFARCTION RATE WAS 7 %. POSTOPERATIVE SUBARACHNOID HEMORRHAGE (SAH) RATE WAS 3 %. INTRAPARENCHYMAL HEMORRHAGE (IPH) RATE WAS 4 %. NO OTHER INFORMATION WAS PROVIDED REGARDING THE RELATIONSHIP TO THE PIPELINE EMBOLIZATION DEVICE. OUT OF THE 14 STUDIES LISTED, ONLY 5 STUDIES LISTED PIPELINE EMBOLIZATION DEVICE AS THE STUDY DEVICE. IN THIS LITERATURE ARTICLE, THE AUTHORS DESCRIBE A META-ANALYSIS RESULTS OF A SYSTEMATIC REVIEW OF THE LITERATURE ON THE TREATMENT OF PCAS WITH FDS WHICH INCLUDED 14 STUDIES, WHICH REPORTED ON A TOTAL OF 225 PCAS IN 220 PATIENTS. THE AUTHORS CONCLUDED THAT FLOW DIVERTER TREATMENT OF PCAS IS AN EFFECTIVE METHOD, WHICH PROVIDES A HIGH RATE OF COMPLETE OCCLUSION AT 6-MONTH DSA. HOWEVER, COMPARED WITH ANTERIOR CIRCULATION ANEURYSMS, PATIENTS WITH PCAS ARE AT SIGNIFICANTLY HIGHER RISK OF MORTALITY, ISCHEMIC STROKE AND PERFORATOR INFARCTION. REFER TO (B)(4) FOR DEATH EVENTS CITATION: WANG CB, SHI WW, ZHANG GX, ET AL. FLOW DIVERTER TREATMENT OF POSTERIOR CIRCULATION ANEURYSMS. A META-ANALYSIS. NEURORADIOLOGY. 2016 APR;58(4):391-400. DOI: 10.1007/S00234-016-1649-2. EPUB 2016 JAN 22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345779 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC NEUROVASCULAR PIPELINE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability