BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1993722 · Received February 16, 2011

    Report

    Report Number
    9616099-2011-00106
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    April 8, 2010
    Report Date
    January 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT DIED. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, HISTORY OF SMOKING (>5PACKS OF CIGARETTES), DIABETES MELLITUS, CORONARY ARTERY DISEASE AND HYPERTENSION. THIS PATIENT MEETS THE HIGH-RISK CRITERIA OF CONTRALATERAL CAROTID OCCLUSION. THE PATIENT WAS ASYMPTOMATIC FOR THE INDEX PROCEDURE. THE LICA TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 2 MM LENGTH, 6.0 MM REFERENCE DIAMETER, SEVERELY CALCIFIED, AND MILDLY TORTUOUS. A 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY SIX MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT EXPIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, TO DATE, HAVE BEEN UNSUCCESSFUL. THE STENT REMAINS IMPLANTED IN THE PATIENT AND THUS UNAVAILABLE FOR ANALYSIS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT MET HIGH-RISK CRITERIA AND HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE SAPPHIRE STUDY INDICATED THAT APPROXIMATELY SIX MONTHS AFTER THE STUDY INDEX PROCEDURE FOR SUCCESSFUL PRECISE 8 X 40 CAROTID STENT IMPLANTATION, THE PATIENT EXPIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE PRECISE STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION. THE PATIENT WAS ASYMPTOMATIC FOR THE INDEX PROCEDURE. THE LICA TARGET LESION WAS REPORTED TO BE: A 90% STENOSIS, 2 MM LENGTH, 6.0 MM REFERENCE DIAMETER, SEVERELY CALCIFIED, AND MILDLY TORTUOUS. A 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE.

    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 13400252

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death ANGIOGUARD 6 MM RX