BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1722004 · Received June 14, 2010

    Report

    Report Number
    9616099-2010-00446
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 18, 2010
    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

    SEVENTEEN MONTHS AFTER HAVING A STENT PLACED IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPIRED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION THE CAUSE OF DEATH REMAINS UNKNOWN. THE REPORT WAS FROM THE (B) (4) STUDY. THE PATIENT WAS A (B) (6) FEMALE WITH A HISTORY OF CABG, RENAL INSUFFICIENCY, DIABETES, CORONARY ARTERY DISEASE, AND HYPERTENSION. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID. LESION LENGTH 25MM AND DIAMETER WAS 7MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS SEVERELY CALCIFIED AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED. A PRECISE PRO RX 8 X 40MM STENT WAS DEPLOYED IN THE TARGET LESION. AN ANGIOGUARD RX, SIZE 6 BASKET, WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. FINAL STENOSIS WAS 8%. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PATIENT LEFT THE ANGIO SUITE. THE PATIENT WAS DISCHARGED 2 DAYS LATER. 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 14013268 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. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    TICLOPIDINE, CLOPIDOGREL, PRASUGREL, HEPARIN.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 46 MG/DL BACK TO BACK WITH A RESULT OF 90 MG/DL WHEN TESTING WAS PERFORMED 1 MINUTE APART ON THE ADVANTAGE SYSTEM. IT WAS NOT PROVIDED WHETHER ANY ACTIONS WERE TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Description of Event or Problem · 1

    THE REPORT WAS FROM THE (B) (4) STUDY. THE PATIENT WAS A (B) (6) FEMALE WITH A HISTORY OF CABG, RENAL INSUFFICIENCY, DIABETES, CORONARY ARTERY DISEASE, AND HYPERTENSION. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID. LESION LENGTH 25MM AND DIAMETER WAS 7MM. PRE-PROCEDURE STENOSIS WAS 80%. THE LESION WAS SEVERELY CALCIFIED AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED. A PRECISE PRO RX 8 X 40MM STENT WAS DEPLOYED IN THE TARGET LESION. AN ANGIOGUARD RX, SIZE 6 BASKET, WAS SUCCESSFULLY DEPLOYED AND RETRIEVED DURING THE PROCEDURE. FINAL STENOSIS WAS 8%. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PATIENT LEFT THE ANGIO SUITE. THE PATIENT WAS DISCHARGED 2 DAYS LATER. THE PATIENT DIED A YEAR AND 5 MONTHS POST-PROCEDURE.

    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 14013268

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death ACETYLSALICYLIC ACID