BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4513585 · Received February 12, 2015

    Report

    Report Number
    2029214-2015-00124
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    June 25, 2014
    Report Date
    January 13, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS CREATED TO CAPTURE THE POST PROCEDURE EXPERIENCED BY THE PATIENT AND ALL RECEIVED FROM THE ARTICLE INFORMATION RECEIVED FROM THE ARTICLE: CHALOUHI ET AL. INTRACERERAL HEMORRHAGE AFTER PIPELINE EMBOLIZATION: MANAGEMENT OF ANTIPLATELET AGENTS AND THE CASE FOR POINT-OF-CARE TESTING -- CASE REPORTS AND REVIEW OF LITERATURE. CLINICAL NEUROLOGY AND NEUROSURGERY 124 (2014) 21-24.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: CHALOUHI ET AL. INTRACERERAL HEMORRHAGE AFTER PIPELINE EMBOLIZATION: MANAGEMENT OF ANTIPLATELET AGENTS AND THE CASE FOR POINT-OF-CARE TESTING -- CASE REPORTS AND REVIEW OF LITERATURE. CLINICAL NEUROLOGY AND NEUROSURGERY 124 (2014) 21-24. IT WAS REPORTED THAT A PATIENT IN HIS/HER (B)(6) HAD A RIGHT SUPRACLINOID ICA (INTERNAL CAROTID ARTERY) ANEURYSM WAS TREATED WITH 2 PIPELINES. FIVE DAYS POST PROCEDURE, THE PATIENT RETURNED WITH AN EXCRUCIATING HEADACHE. THE PATIENT WAS NEUROLOGICALLY INTACT; HOWEVER HEAD CT (COMPUTED TOMOGRAPHY) DEMONSTRATED A RIGHT TEMPORAL LOBE HEMORRHAGE. FOLLOWING CLOPIDOGREL ADJUSTMENTS AND A PLATELET TRANSFUSION, THE PATIENT IMPROVED CLINICALLY AND WAS DISCHARGED NEUROLOGICALLY INTACT. THE INFORMATION WAS RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2015-00123.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104124 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S