BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3038851 · Received April 5, 2013

    Report

    Report Number
    9616099-2013-00210
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) REGISTRY THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT OF RETINAL ARTERY EMBOLUS RESULTING IN A LEFT VISUAL FIELD DISTURBANCE OF RIGHT EYE APPROXIMATELY ONE MONTH POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE SAPPHIRE STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND SEVERELY TORTUOUS. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DELIVERED DISTAL TO THE LESION. THE LESION WAS PRE-DILATED AND A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE ANGIOGUARD FILTER BASKET WAS REMOVED FROM THE PATIENT. UPON REMOVAL THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY. APPROXIMATELY A MONTH POST PROCEDURE THE PATIENT SUFFERED A NEUROLOGICAL EVENT DESCRIBED AS A LEFT VISUAL FIELD DISTURBANCE OF RIGHT EYE. THE PATIENT HAS BEEN ASYMPTOMATIC SINCE THE RIGHT ICA STENTING. THE PATIENT HAD A SIMILAR SYMPTOM AFFECTING HER LEFT EYE BEFORE THE RIGHT ICA STENTING. SHE WAS BELIEVED TO HAVE A RETINAL EMBOLIC EVENT. CT SCAN OF THE HEAD WAS PERFORMED AT THE 30 DAY FOLLOW UP AND REVEALED A SMALL INFARCT IN THE LEFT TEMPORAL LOBE. THERE WAS NO NEW INFARCT OF INTRACRANIAL HEMORRHAGE. THE EVENT WAS EVALUATED AND DETERMINED TO UN-RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE INDEX PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RETINAL ARTERY EMBOLISM IS AN OBSTRUCTION IN A BLOOD VESSEL DUE TO A BLOOD CLOT OR OTHER FOREIGN MATTER THAT GETS STUCK WHILE TRAVELLING THROUGH THE BLOODSTREAM. IN THIS CASE IT REFERS TO THE OBSTRUCTION OR BLOCKAGE OF THE RETINAL VASCULAR LUMEN BY AN EMBOLUS. THE LACK OF OXYGEN DELIVERY TO THE RETINA DURING THE BLOCKAGE MAY RESULT IN SEVERE LOSS OF VISION. THE AREA OF RETINA AFFECTED IS ASSOCIATED WITH THE AREA AND DEGREE OF VISUAL LOSS. 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. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    CT SCAN OF THE HEAD WAS PERFORMED AT THE 30 DAY FOLLOW UP. EXAMINATION SHOWS NO CHANGE IN THE APPEARANCE OF A 1.6 X 1.0 CM HYPODENSITY IN THE ANTERIOR BASE OF LEFT TEMPORAL LOBE SUGGESTING OLD INFARCT. THERE ARE NO NEW HYPODENSE OR HYPERDENSE INTRACRANIAL MASSES. SLIGHT HYPODENSITY IN WHITE MATTER DUE TO SMALL VESSEL DISEASE IS NOTED. A 6.0 MM THICK CALCIFICATION IN THE M1 RIGHT MIDDLE CEREBRAL ARTERY JUST ABOVE THE CLINOID PROCESS IS NOTED. THE CALVARIUM APPEARS NORMAL. IMPRESSION: SMALL INFARCT IN LEFT TEMPORAL LOBE AND AGE-RELATED MILD CORTICAL ATROPHY ARE UNCHANGED IN THE INTERVAL. CALCIFICATION IN THE PROXIMAL RIGHT MIDDLE CEREBRAL ARTERY IS ALSO UNCHANGED COMPARED TO PRIOR EXAM OF (B)(6) 2012. THERE IS NO NEW INFARCT OF INTRACRANIAL HEMORRHAGE. 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

    AS REPORTED BY (B)(4) REGISTRY, THE PATIENT EXPERIENCED A NEUROLOGICAL EVENT OF RETINAL ARTERY EMBOLUS RESULTING IN A LEFT VISUAL FIELD DISTURBANCE OF RIGHT EYE APPROXIMATELY ONE MONTH POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND SEVERELY TORTUOUS. AN ANGIOGUARD ((B)(4) / LOT 70912540) EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DELIVERED DISTAL TO THE LESION. THE LESION WAS PRE-DILATED AND A PRECISE ((B)(4)/ LOT 15686269) STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE ANGIOGUARD FILTER BASKET WAS REMOVED FROM THE PATIENT. UPON REMOVAL THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. APPROXIMATELY A MONTH POST PROCEDURE, THE PATIENT SUFFERED A NEUROLOGICAL EVENT DESCRIBED AS A LEFT VISUAL FIELD DISTURBANCE OF RIGHT EYE. THE PATIENT HAS BEEN ASYMPTOMATIC POST RIGHT ICA STENTING UNTIL ONE WEEK AGO SHE SAW LESS CLEAR OF LEFT VISUAL FIELD ON THE RIGHT EYE WITHOUT CHANGE OF RIGHT EYE. SHE STATES THAT HER CLOUDY LEFT VISUAL FIELD OF THE RIGHT EYE HAS BEEN IMPROVING IN THE LAST WEEK. SHE HAD A SIMILAR SYMPTOM AFFECTING HER LEFT EYE BEFORE THE RIGHT ICA STENTING. SHE WAS BELIEVED TO HAVE A RETINAL EMBOLIC EVENT. FURTHER TEST SHOWED THAT HER LEFT ICA WAS LESS THAN 50% STENOSIS. THE EVENT WAS EVALUATED AND DETERMINED TO UN-RELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140184 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15686269

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R ANGIOGUARD