BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1941166 · Received December 29, 2010

    Report

    Report Number
    9616099-2010-01026
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    July 3, 2010
    Report Date
    November 16, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR INSPECTION. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT UNDERWENT CAROTID STENT IMPLANTATION AND APPROXIMATELY THREE DAYS POST INDEX PROCEDURE SUFFERED AN ISCHEMIC STROKE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING CARDIAC ARRHYTHMIAS. THIS PATIENT MEETS THE HIGH-RISK CRITERIA OF AGE GREATER THAN 75 YEARS. THE LICA TARGET LESION WAS REPORTED TO BE: AN 85% STENOSIS, 36 MM LENGTH, 7.1 MM VESSEL DIAMETER, SEVERELY CALCIFIED, AND MODERATELY TORTUOUS. THE LESION WAS PRE-DILATED. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 10%. A 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED DURING THE PROCEDURE. THERE WERE NO REPORTED DEVICE DEVIATIONS, PROCEDURAL COMPLICATIONS, OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT REPORTED AS APHASIA AND RIGHT-SIDED VISUAL FIELD LOSS. PER MRI EXAMINATION THE PATIENT SUFFERED AN ISCHEMIC STROKE. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE, ANTICOAGULATION, OR ANY CORDIS PRODUCT. THE PATIENT'S SYMPTOMS FULLY RESOLVED WITH NO ACTION TAKEN. THE PATIENT WAS DISCHARGED FOURTEEN DAYS AFTER THE INDEX PROCEDURE. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15041758 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). 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 15041758. 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. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS DEVICE.

    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 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY (LICA) DURING THE STUDY INDEX PROCEDURE. A 6 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED DURING THE PROCEDURE. THERE WERE NO REPORTED DEVICE DEVIATIONS, PROCEDURAL COMPLICATIONS, OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ADVERSE EVENT REPORTED AS APHASIA AND RIGHT-SIDED VISUAL FIELD LOSS. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE, ANTICOAGULATION, OR ANY CORDIS PRODUCT. THE PATIENT'S SYMPTOMS FULLY RESOLVED WITH NO ACTION TAKEN. THE PATIENT WAS DISCHARGED FOURTEEN DAYS AFTER THE INDEX PROCEDURE. THE LICA TARGET LESION WAS REPORTED TO BE: AN 85% STENOSIS, 36 MM LENGTH, 7.1 MM VESSEL DIAMETER, SEVERELY CALCIFIED, AND MODERATELY TORTUOUS. THE LESION WAS PRE-DILATED. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE RESIDUAL STENOSIS WAS 10%. ADDENDUM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD AN ISCHEMIC STROKE BASED ON AN MRI EXAMINATION.

    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 15041758

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L ANGIOGUARD 6 MM EMBOLIC PROTECTION DEVICE