BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 6701887 · Received July 11, 2017

    Report

    Report Number
    2029214-2017-00882
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    June 14, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETUNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE FLOW DIVERTER WAS REPORTED TO HAVE PERFORMED AS INTENDED BY SUCCESSFUL DEPLOYED AND IMPLANTATION WITHIN THE INTENDED TREATING LOCATION. THEREFORE, THERE IS NO ALLEGATION THAT THE DEVICE WAS DEFECTIVE OR THAT A MALFUNCTION OCCURRED DURING ITS USE. THIS EVENT APPEARS TO BE MORE PATIENT CONDITION AND PROCEDURE RELATED. HOWEVER, ITS EXACT CAUSE IS UNKNOWN. THROMBOEMBOLISM IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND IS DOCUMENTED IN OUR DEVICE'S INSTRUCTION FOR USE. LINKED MDRS EVENTS: 2029214-2017-00880 AND 2029214-2017-00881.

    Description of Event or Problem · 1

    CITATION: ¿ANTIPLATELET DRUG RESISTANCE DID NOT INCREASE THE THROMBOEMBOLIC EVENTS AFTER STENT-ASSISTED COILING OF UNRUPTURED INTRACRANIAL ANEURYSM: A SINGLE CENTER EXPERIENCE OF 99 CASES¿. JIHYE SONG, YONG SAM SHIN. NEUROL SCI (2017) 38:879¿885 DOI 10.1007/S10072-017-2859-Z MEDTRONIC RECEIVED THE FOLLOWING REPORTS: A (B)(6) FEMALE PATIENT WAS TREATED WITH TWO FLOW DIVERTER DEVICES (4.25-25 AND 4.25-20), FOR A LEFT INTERNAL CAROTID ARTERY (ICA) CAVERNOUS ANEURYSM. THE PATIENT WAS REPORTED TO HAVE A DELAYED THROMBOEMBOLIC EVENT. THE PATIENT HAD NO SYMPTOMS AND WAS ON ASPIRIN. IMAGING FINDING REVEALED LEFT FRONTAL AND BASAL GANGLIA INFARCT. THIS EVENT WAS CONSERVATIVELY MANAGED. AT ONE MONTH FOLLOW UP, THE MRS WAS 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483327 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77425-20

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention