BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2181756 · Received July 27, 2011

    Report

    Report Number
    9616099-2011-00548
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    January 27, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE STUDY COORDINATOR AT THE SITE. THE DEATH CERTIFICATE HAS BEEN OBTAINED, AND THE NOTED CAUSE OF DEATH WAS COPD, FROM WHICH THE PATIENT HAD SUFFERED FROM FOR SOME TIME. BASED ON THIS INFORMATION, THE EVENT IS NO LONGER CONSIDERED REPORTABLE. NO FURTHER FOLLOWUP WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THIS (B)(6) MALE PATIENT UNDERWENT SUCCESSFULLY STENTING OF THE RIGHT INTERNAL CAROTID ON (B)(6) 2010. RECENT INFORMATION FROM THE SAPPHIRE DATABASE INDICATES THAT THE PATIENT DIED ON (B)(6) 2011. THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. THE DEATH CERTIFICATE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED.

    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 15061389

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 5MM ANGIOGUARD