BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1924015 · Received December 14, 2010

    Report

    Report Number
    9616099-2010-00949
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION THE COMPLAINT RECEIVED STATES THAT THIS (B)(6) STUDY PATIENT UNDERWENT CAROTID STENT IMPLANTATION AND APPROXIMATELY FIVE DAYS POST INDEX PROCEDURE SUFFERED AN ISCHEMIC STROKE. THIS IS AN (B)(6) MALE PATIENT WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, CABG, DIABETES MELLITUS, CORONARY ARTERY DISEASE, AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). THIS PATIENT MEETS THE HIGH-RISK CRITERIA FOR AGE GREATER THAN 75 YEARS. THE TARGET LESION, LICA (LEFT INTERNAL CAROTID ARTERY) WAS DESCRIBED AS AN 85% STENOSIS, 10 MM LENGTH, 8.0 MM VESSEL DIAMETER, AND MODERATELY CALCIFIED. A PRECISE 8 X 30 STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE INDEX PROCEDURE. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THE RESIDUAL STENOSIS WAS 10%. THE ANGIOGUARD DEVICE WAS REMOVED AND NO DEBRIS WAS NOTED. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE CHARACTERIZED BY LEFT HEMIPARESIS. THE ONSET WAS GRADUAL AND THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THE STUDY PERSONNEL EVALUATED THE EVENT AND REPORTED IT TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE, OR ANTICOAGULATION. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15189331 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15189331. ISCHEMIC STROKE IS A WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 30 STENT IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. AN ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE CHARACTERIZED BY LEFT HEMIPARESIS. THE ONSET WAS GRADUAL AND THE PATIENT'S RECOVERY WAS PARTIAL WITH MINOR RESIDUALS. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE, OR ANTICOAGULATION. THE PATIENT WAS ASYMPTOMATIC. THE TARGET LESION WAS THE PROXIMAL LICA. THE LESION WAS REPORTED TO BE: AN 85% STENOSIS, 10 MM LENGTH, 8.0 MM VESSEL DIAMETER, AND MODERATELY CALCIFIED. A 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THE RESIDUAL STENOSIS WAS 10%. THE ANGIOGUARD DEVICE WAS REMOVED AND NO DEBRIS WAS NOTED.

    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 15189331

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L ANGIOGUARD RX 6 MM EMBOLIC PROTECTION DEVICE