BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3771812 · Received April 24, 2014

    Report

    Report Number
    9616099-2014-00283
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT HAD A PRECISE 9 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY (RICA) DURING THE STUDY INDEX PROCEDURE. A 7 MM. ANGIOGUARD WAS USED. THE RESIDUAL STENOSIS WAS 20%. THERE WERE NO PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. POST-PROCEDURE THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE. THE EVENT WAS CHARACTERIZED BY DYSARTHRIA, LEFT HEMINEGLECT/HEMIPARESIS. THE ONSET WAS SUDDEN. THE RECOVERY WAS UNKNOWN. THE EVENT WAS UNRELATED TO A CORDIS DEVICE OR ANTICOAGULATION AND WAS RELATED TO THE INDEX PROCEDURE. THE OSTIAL RICA TARGET LESION WAS REPORTED TO BE: AN 85% STENOSIS, 25 MM. IN LENGTH, ABSENT OF THROMBUS, 7 MM. REFERENCE DIAMETER, MODERATELY CALCIFIED/TORTUOUS, ECCENTRIC, AND ULCERATED. THE LESION WAS PRE-DILATED. DEBRIS WAS NOTED IN THE ANGIOGUARD DEVICE POST-PROCEDURE. ADDENDUM: ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO ADDITIONAL TREATMENT OR INTERVENTION WAS PROVIDED TO THE PATIENT IN RELATION TO THE REPORTED ADVERSE EVENT OF ISCHEMIC STROKE. THE PATIENT WAS DISCHARGED TO A NURSING FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC STROKE/CEREBROVASCULAR ACCIDENT 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. EIGHTY PERCENT 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- MODERATELY CALCIFIED/TORTUOUS, AND PROCEDURAL FACTORS-DEBRIS NOTED IN THE FILTER, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    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 THE PATIENT HAD A PRECISE 9 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY (RICA) DURING THE STUDY INDEX PROCEDURE. A 7 MM. ANGIOGUARD WAS USED. THE RESIDUAL STENOSIS WAS 20%. THERE WERE NO PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. POST-PROCEDURE THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ISCHEMIC STROKE. THE EVENT WAS CHARACTERIZED BY DYSARTHRIA, LEFT HEMINEGLECT/ HEMIPARESIS. THE ONSET WAS SUDDEN. THE RECOVERY WAS UNKNOWN. THE EVENT WAS UNRELATED TO A CORDIS DEVICE OR ANTICOAGULATION AND WAS RELATED TO THE INDEX PROCEDURE. THE OSTIAL RICA TARGET LESION WAS REPORTED TO BE: AN 85% STENOSIS, 25 MM. IN LENGTH, ABSENT OF THROMBUS, 7 MM. REFERENCE DIAMETER, MODERATELY CALCIFIED/TORTUOUS, ECCENTRIC, AND ULCERATED. THE LESION WAS PRE-DILATED. DEBRIS WAS NOTED IN THE ANGIOGUARD DEVICE POST-PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249877 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15665142

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| S 7 MM ANGIOGUARD