BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2000195 · Received February 24, 2011

    Report

    Report Number
    9616099-2011-00126
    Event Type
    Death
    Date Received
    February 24, 2011
    Date of Event
    August 16, 2009
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4), THE PATIENT EXPIRED APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE INDEX PROCEDURE. THE LESION WAS DESCRIBED AS 90% STENOSED, NON-THROMBOSED, 30MM IN LENGTH, ECCENTRIC, ARCH TYPE II, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 7.0MM IN DIAMETER AND MILDLY TORTUOUS. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AND AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. THE PATIENT¿S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, SEVERE AORTIC/MITRAL VALVE DISEASE, CORONARY ARTERY DISEASE, AND HYPERTENSION. 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. REVIEW OF LOT 14057162 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IT IS POSSIBLE THAT THE PATIENT'S SIGNIFICANT MEDICAL HISTORY MAY HAVE CONTRIBUTED AS ETIOLOGY OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6), THE PATIENT DIED APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT COMMON CAROTID ARTERY. THE PATIENT WAS ASYMPTOMATIC PRIOR TO THE INDEX PROCEDURE. THE LESION WAS DESCRIBED AS 90% STENOSED, NON-THROMBOSED, 30MM IN LENGTH, ECCENTRIC, ARCH TYPE II, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 7.0MM IN DIAMETER AND MILDLY TORTUOUS. A 5MM ANGIOGUARD RX WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AND AN 8X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS NOTED IN THE BASKET. RESIDUAL STENOSIS WAS 10%. THERE WERE NO AIR BUBBLES PRESENT. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT'S FAMILY DID NOT HAVE THAT INFORMATION. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO DEATH CERTIFICATE WAS AVAILABLE.

    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 14057162

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 5MM ANGIOGUARD RX