BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1040384 · Received May 6, 2008

    Report

    Report Number
    9616099-2008-01244
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED PRIOR TO INSERTING DEVICE INTO THE PT, THE STENT PREMATURELY DEPLOYED. THE INTENDED PROCEDURE WAS CAROTID ANGIOPLASTY. THE PHYSICIAN USED ANOTHER STENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENS NIM CORDIS DE MEXICO NA 13131152

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK