BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1212547 · Received October 27, 2008

    Report

    Report Number
    9616099-2008-02532
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBER IS: 1016427-2008-00281. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE ANGIOGUARD FILTER REDUCED THE AMOUNT OF FLOW, EVEN AFTER IT WAS CLEANED OUT. THERE WAS VERY LITTLE FLOW. IT WAS NOTED THAT THE PT HAD A 9 X 40 MM PRECISE STENT IMPLANTED BEFORE THE "SLOW FLOW" OCCURRED, IN ADDITION TO HAVING THE ANGIOGUARD STILL IN PLACE. THE ANGIOGUARD WAS CLEANED OUT WITH SALINE AND DID NOT HAVE TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention