BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1063295 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01532
    Event Type
    Death
    Date Received
    June 17, 2008
    Date of Event
    February 3, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE PT WAS A MALE. THE PT HAD A HISTORY OF HYPERLIPIDEMIA, HYPERTENSION, AND RESTENOSIS AT THE SITE OF A PREVIOUS CEA. THE PT WAS 73 AT THE TIME OF THE INDEX PROCEDURE. THE INDEX PROCEDURE TOOK PLACE IN 2007. THE TARGET LESION WAS THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE VESSEL WAS TORTUOUS WITH >= 2 BENDS. THE LESION LENGTH WAS 15 MM AND THE VESSEL DIAMETER WAS 6.1 MM. PRE-PROCEDURE STENOSIS WAS 80%. AN ANGIOGUARD WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. THERE WAS NO DEBRIS IN THE BASKET. A PRECISE RX 8 X 30 MM STENT WAS DEPLOYED AT THE TARGET LESION. POST-PROCEDURE STENOSIS WAS 10%. THERE WAS NO REPORT OF COMPLICATION OR MALFUNCTION DURING THE PROCEDURE. THE PT WAS DISCHARGED THE FOLLOWING DAY. THE PT PASSED AWAY APPROX 3 AND A HALF MONTHS LATER (2008). NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13262589

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death