BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1743855 · Received July 1, 2010

    Report

    Report Number
    9616099-2010-00510
    Event Type
    Death
    Date Received
    July 1, 2010
    Date of Event
    November 27, 2009
    Report Date
    June 4, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICAL HISTORY INCLUDES: HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, SEVERE AORTIC / MITRAL VALVE DISEASE, RENAL INSUFFICIENCY, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, AND HYPERTENSION. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S:9616099-2010-00509 AND 9616099-2010-00510.

    Additional Manufacturer Narrative · 1

    THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT AND CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PATIENT'S MEDICAL HISTORY INCLUDES: HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, SEVERE AORTIC / MITRAL VALVE DISEASE, RENAL INSUFFICIENCY, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, AND HYPERTENSION. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S:9616099-2010-00509 AND 9616099-2010-00510.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING THE PKS LYONS DISSECTING FORCEPS, THE JAW DETACHED FROM THE DEVICE AND FELL INTO THE PT'S ABDOMEN. THE JAW WAS RECOVERED FROM THE PT WITH NO PT HARM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENTS.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FROM THE (B) (4) STUDY INDICATED THAT APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE THE PATIENT DIED. THIS PATIENT HAD TWO 10 X 30MM PRECISE STENTS IMPLANTED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY WITHOUT COMPLICATION. THE TARGET WAS 90% STENOSED AND WAS SEVERELY CALCIFIED. APPROXIMATELY SEVEN MONTHS POST PROCEDURE, THE PATIENT DIED. THE CAUSE OF DEATH IS NOT KNOWN AND NO AUTOPSY WAS PERFORMED. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE STUDY COORDINATOR TO OBTAIN RECORDS REGARDING THIS EVENT; HOWEVER, THEY HAVE NOT BEEN SUCCESSFUL. NO CAUSE OF DEATH CAN BE DETERMINED AT THIS TIME.

    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 13447312

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death