BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2883570 · Received December 21, 2012

    Report

    Report Number
    9616099-2012-00762
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. 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 15529358 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT THE PATIENT HAD A PRECISE 8 X 40 STENT SUCCESSFULLY IMPLANTED IN THE MID LEFT INTERNAL CAROTID ARTERY (LICA). THE DAY AFTER THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE CHARACTERIZED BY BEHAVIORAL CHANGE, APHASIA AND OTHER. PATIENT RECOVERY WAS REPORTED TO BE PARTIAL WITH MINOR RESIDUALS. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE INDEX PROCEDURE. THE EVENT WAS REPORTED TO NOT BE RELATED TO A CORDIS PRODUCT AND WAS RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS ASYMPTOMATIC FOR THE PROCEDURE. THE MID LICA TARGET LESION WAS REPORTED TO HAVE AN 80% STENOSIS, 7 MM. IN LENGTH, ABSENT OF THROMBUS, 7 MM. REFERENCE DIAMETER, AND NOT CALCIFIED/TORTUOUS. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, SMOKING AND HYPERTENSION WIT HIGH RISK CRITERIA INCLUDING POST RADIATION TREATMENT. THE PRODUCT WAS NOT RETURNED 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 15529358 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). 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. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH; 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD A PRECISE 8 X 40 STENT SUCCESSFULLY IMPLANTED IN THE MID LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION DURING THE STUDY INDEX PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE CHARACTERIZED BY BEHAVIORAL CHANGE, APHASIA AND OTHER. THE PATIENT RECOVERY WAS REPORTED TO BE PARTIAL WITH MINOR RESIDUALS. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE INDEX PROCEDURE. THE EVENT WAS REPORTED TO NOT BE RELATED TO A CORDIS PRODUCT AND WAS RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS ASYMPTOMATIC FOR THE PROCEDURE. THE MID LICA TARGET LESION WAS REPORTED TO BE: AN 80% STENOSIS, 7 MM. IN LENGTH, ABSENT OF THROMBUS, 7 MM. REFERENCE DIAMETER, AND NOT CALCIFIED/TORTUOUS. THE LESION WAS PRE-DILATED. THE RESIDUAL STENOSIS WAS 0%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE 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 15529358

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L ANGIOGUARD 6 MM