BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2040238 · Received April 5, 2011

    Report

    Report Number
    9616099-2011-00224
    Event Type
    Death
    Date Received
    April 5, 2011
    Date of Event
    June 23, 2010
    Report Date
    March 10, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE SAPPHIRE STUDY INDICATED THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF COPD (SEVERE PULMONARY DISEASE), CABG, AND SMOKING. THE TARGET LESION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE STENOSIS WAS 90%. LESION LENGTH WAS 10MM AND DIAMETER WAS 5MM. THE LESION WAS PRE-DILATED AND A PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. POST-PROCEDURE STENOSIS WAS 10%. AN ANGIOGUARD RX SIZE 6 WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 4 MONTHS POST-PROCEDURE, THE PATIENT DIED. NO FURTHER INFORMATION IS AVAILABLE. 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. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT OF AN UNKNOWN CAUSE OF DEATH IS BEING UNREPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE CONTACT AT THE ACCOUNT STATES THAT THE OFFICIAL CAUSE OF DEATH FOR THIS PATIENT WAS METASTATIC LUNG CANCER. A DEATH CERTIFICATE HAS BEEN RECEIVED. PLEASE UPDATE YOUR FILES AS THE EVENT WAS NOT RELATED TO THE CORDIS PRODUCT. NO ADDITIONAL FOLLOW-UP WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THE REPORT FROM THE (B)(4) INDICATED THE PATIENT WAS A (B)(6) OLD MALE WITH A HISTORY OF COPD (SEVERE PULMONARY DISEASE), CABG, AND SMOKING. THE TARGET LESION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE STENOSIS WAS 90%. LESION LENGTH WAS 10MM AND DIAMETER WAS 5MM. THE LESION WAS PRE-DILATED. A PRECISE PRO RX 8 X 30MM STENT WAS DEPLOYED AT THE TARGET LESION. POST-PROCEDURE STENOSIS WAS 10%. AN ANGIOGUARD RX SIZE 6 WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY 4 MONTHS POST-PROCEDURE, THE PATIENT DIED. NO FURTHER INFORMATION IS 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 15036727

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death ASPIRIN AND CLOPIDOGREL