BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 9818120 · Received March 11, 2020

    Report

    Report Number
    2029214-2020-00213
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    January 1, 2014
    Report Date
    March 11, 2020
    Manufacturer
    MEDTRONIC
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LI W, TIAN Z, ZHU W, ET AL. HEMODYNAMIC ANALYSIS OF POSTOPERATIVE RUPTURE OF UNRUPTURED INTRACRANIAL ANEURYSMS AFTER PLACEMENT OF FLOW-DIVERTING STENTS: A MATCHED CASE-CONTROL STUDY. AJNR AMERICAN JOURNAL OF NEURORADIOLOGY. 2019;40(11):1916-1923. DOI:10.3174/AJNR.A6256. MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF POSTOPERATIVE RUPTURE OF INTRACRANIAL ANEURYSM AFTER PIPELINE PLACEMENT. THE AUTHORS REVIEWED TEN PATIENTS WITH POSTOPERATIVE ANEURYSM RUPTURE, AND TWENTY PATIENTS WITHOUT POSTOPERATIVE ANEURYSM RUPTURE. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. THE STUDY TOOK PLACE BETWEEN 2014 AND 2018. THE ARTICLE STATES THAT TWELVE PATIENTS EXPERIENCED UNEXPECTED ANEURYSM SUBARACHNOID HEMORRHAGE COMPLICATIONS, AND 3 PATIENTS HAD UNSTABLE FLOW AFTER PED TREATMENT. IT WAS NOTED THAT THERE WAS MORTALITY AS A COMPLICATION RELATED TO INTRACRANIAL HEMORRHAGE, BUT NO ALLEGATIONS OF DEATH WERE ALLEGED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283089 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other