BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1192204 · Received October 7, 2008

    Report

    Report Number
    9616099-2008-02400
    Event Type
    Death
    Date Received
    October 7, 2008
    Date of Event
    December 4, 2007
    Report Date
    September 9, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT WE RECEIVED FROM THE STUDY INDICATED THAT APPROXIMATELY THREE MONTHS POST STENTING PROCEDURE, THE PATIENT DIED. DURING THE INDEX PROCEDURE, THE PATIENT WAS SYMPTOMATIC. THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE RIGHT SIDE OF THE PROXIMAL INTERNAL CAROTID. THE CONTRALATERAL CAROTID WAS NOT OCCLUDED. PRIOR TO THE INDEX PROCEDURE, AN ANGIOGRAM WAS CONDUCTED. THE TARGET LESION PRESENTED 90% STENOSIS, WAS 5.0 MM LONG AND PRESENTED A 5.0 MM REFERENCE VESSEL DIAMETER WITH AN AORTIC ARCH TYPE II. THE LESION PRESENTED MILD - CONCENTRIC CALCIFICATION AND MODERATE GRADE VESSEL TORTUOSITY. DURING THE PROCEDURE, THE LESION WAS SUCCESSFULLY PRE-DILATED. THEN A 6MM ANGIOGUARD WAS ADVANCED AND DEPLOYED WITHOUT DIFFICULTIES. THEN AN 8X30MM PRECISE STENT WAS IMPLANTED AT THE TARGET LESION WITHOUT ANY COMPLICATIONS. NO MALFUNCTION OR ADVERSE EVENTS WERE REPORTED DURING THE STENT IMPLANT. THE ANGIOGUARD FILTER WAS RETRIEVED WITHOUT ANY COMPLICATIONS. THERE WERE NO TRACES OF ANY DEBRIS ON THE FILTER. POST-STENTING, THE TARGET LESION PRESENTED A 20% DIAMETER STENOSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE, THERE WAS NO NEUROLOGICAL DEFICIT. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED. THIRTY DAYS POST PROCEDURE, THE PATIENT HAD A FOLLOW UP WITH A NEUROLOGICAL EVALUATION; NEUROLOGICAL RESULTS REMAINED UNCHANGED, THE PATIENT HAD NOT EXPERIENCED ANY ADVERSE EVENTS. THEREFORE, REMAINED ASYMPTOMATIC. APPROXIMATELY THREE MONTHS POST INDEX PROCEDURE, THE PATIENT DIED. THE DEATH WAS REPORTED TO BE UNRELATED TO THE DEVICE AND TO THE INDEX PROCEDURE. HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death BIVALIRUDIN| CLOPIDOGREL| ASPIRIN