BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2003927 · Received March 1, 2011

    Report

    Report Number
    9616099-2011-00151
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    January 10, 2010
    Report Date
    February 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT EXPIRED APPROXIMATELY 39 DAYS POST INDEX PROCEDURE. THIS WAS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING CAD S/P CABG, SMOKING (>5 PPD), AND HYPERTENSION. THE PATIENT WAS ASYMPTOMATIC FOR THE STUDY INDEX PROCEDURE. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA). THE LESION WAS REPORTED TO BE: A 90% STENOSIS, 30 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A 6 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THIRTY-NINE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION. THE STENT REMAINS IMPLANTED 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 WAS OF ADVANCED AGE 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 (B)(4) STUDY INDICATED THAT THIRTY-NINE DAYS AFTER THE INDEX PROCEDURE FOR PRECISE 8 X 40 CAROTID STENT IMPLANTATION, THE PATIENT EXPIRED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE PATIENT WAS ASYMPTOMATIC FOR THE STUDY INDEX PROCEDURE. THE TARGET LESION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA). THE LESION WAS REPORTED TO BE: A 90% STENOSIS, 30 MM LENGTH, MILDLY CALCIFIED, NOT TORTUOUS, AND ECCENTRIC. THE LESION WAS PRE-DILATED. A 6 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE 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 15004295

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death 6 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE