BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2173933 · Received July 24, 2011

    Report

    Report Number
    9616099-2011-00494
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEIZURES OF UNKNOWN ETIOLOGY CAUSED THE DEFICIT. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC AND WITH A 90% STENOSIS IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS 20MM LONG AND ECCENTRIC. THE LESION WAS PRE-DILATED AND A 10 X 40MM PRECISE PRO RX WAS DEPLOYED WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. AN 8 X 30MM PRECISE PRO RX WAS THEN DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. AN ANGIOGUARD RX DEVICE WAS SUCCESSFULLY DEPLOYED AND RETRIEVED. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. THE PATIENT HAD AN OCCLUSION IN THE CONTRALATERAL CAROTID. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO MAJOR ADVERSE EVENT. THE 30 DAYS FOLLOW UP WAS PERFORMED AND THERE WAS NO MAJOR ADVERSE EVENT. THE 12 MONTHS FOLLOW UP WAS PERFORMED AND THE PATIENT HAD AN ADVERSE EVENT (AS INDICATED ABOVE). CONCOMITANT MEDICAL PRODUCTS: 8 X 30MM PRECISE PRO RX. INTRA-PROCEDURE: HEPARIN. PRE-PROCEDURE, POST-PROCEDURE AND DISCHARGE: CLOPIDOGREL AND ASPIRIN. THIS IS ONE OF TWO DEVICES USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00493 AND 9616099-2011-00494. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY TEN MONTHS AFTER STENTING OF A RIGHT INTERNAL CAROTID ARTERY OSTIAL LESION IN A PATIENT WITH CONTRALATERAL OCCLUSION, THE PATIENT EXPERIENCED A BEHAVIORAL CHANGE; ALTERED MENTAL STATE AND SYNCOPE. THIS WAS DIAGNOSED AS A SEIZURE OF UNKNOWN ETIOLOGY WHICH WAS NOT RELATED TO A SPECIFIC SIDE OF THE BRAIN. ADDITIONAL INFORMATION REPORTED IT WAS A NEW ONSET OF SEIZURES WITH EEG SIGNIFICANT FOR MODERATE SLOWING OF THE BACKGROUND OVER LEFT HEMISPHERE WITH COULD BE RELATED TO PREVIOUS KNOWN INFARCT IN THAT REGION; HOWEVER IT COULD BE POSTICTAL IN NATURE. THE EVENT HAD A SUDDEN ONSET AND LASTED MORE THAN 24 HOURS AND TREATED WITH DILANTIN. THE PATIENT HAD FULL RECOVERY WITH NO DEFICIT. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE. APPROXIMATELY A MONTH LATER, THE PATIENT EXPERIENCED BEHAVIORAL CHANGE; DECREASED LEVEL OF CONSCIOUSNESS AND APHASIA DIAGNOSED AS SEIZURE OF UNKNOWN ETIOLOGY WHICH WAS NOT RELATED TO A SPECIFIC SIDE OF THE BRAIN. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD STOPPED HIS SEIZURE MEDICATION ABOUT 1 MONTH BEFORE THIS SECOND SEIZURE AND HAD BEEN DRAGGING HIS RIGHT SIDE MORE THAN USUAL. THE PATIENT HAD FULL RECOVERY WITH NO DEFICIT. THE DURATION OF THE EVENT WAS MORE THAN 24 HOURS AND TREATED WITH KEPPRA. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED ASYMPTOMATIC AND WITH A 90% STENOSIS IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS 20MM LONG AND ECCENTRIC. THE LESION WAS PRE-DILATED AND A 10X40 PRECISE PRO RX FOLLOWED BY AN 8X30 PRECISE PRO RX WAS DEPLOYED WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. AN ANGIOGUARD RX DEVICE WAS SUCCESSFULLY DEPLOYED AND RETRIEVED. THERE WAS NO NEUROLOGICAL DEFICIT WHEN THE PATIENT LEFT THE ANGIOGRAPHY SUITE. THE PATIENT HAD AN OCCLUSION IN THE CONTRALATERAL CAROTID. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA AND SMOKING. HIGH RISK CRITERIA INCLUDE CONTRALATERAL CAROTID OCCLUSION AND POST RADIATION TREATMENT. ADDITIONAL INFORMATION REPORTED A HISTORY OF MULTIPLE CEREBRAL VASCULAR ACCIDENTS (CVA). THE STENT REMAINS IMPLANTED. 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 14058797 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. SEIZURES ARE A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT HISTORY INCLUDING CONTRALATERAL OCCLUSION AND PREVIOUS CVAS, VESSEL CHARACTERISTICS AND PHARMACEUTICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. BASED ON THE AVAILABLE INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE OR DEFINITIVE RELATIONSHIP TO THE DEVICE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO DEVICES USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00493 AND 9616099-2011-00494.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY TEN MONTHS AFTER THE PROCEDURE THE PATIENT EXPERIENCED A BEHAVIORAL CHANGE; ALTERED MENTAL STATE AND SYNCOPE. THE DIAGNOSIS OF THE EVENT IS SEIZURE. THE EVENT HAD A SUDDEN ONSET AND LASTED MORE THAN 24 HOURS. THE EVENT WAS TREATED WITH DILANTIN. THE PATIENT HAD FULL RECOVERY WITH NO DEFICIT. THE EVENT DID NOT REQUIRE EMERGENCY CEA SURGERY. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE. THERE WAS NO PRESENCE OF BABINSKI. THE EVENT WAS NOT RELATED TO A SPECIFIC SIDE OF THE BRAIN. SEIZURES OF UNKNOWN ETIOLOGY CAUSED THE DEFICIT. APPROXIMATELY A MONTH LATER, THE PATIENT HAD A SECOND ADVERSE EVENT. THE PATIENT HAD BEHAVIORAL CHANGE; DECREASED LEVEL OF CONSCIOUSNESS AND APHASIA. THE DIAGNOSIS OF THE EVENT IS SEIZURE. THE PATIENT HAD FULL RECOVERY WITH NO DEFICIT. THE DURATION OF THE EVENT WAS MORE THAN 24 HOURS. THE EVENT WAS TREATED WITH KEPPRA. THE EVENT HAD SUDDEN ONSET AND DID NOT REQUIRE EMERGENCY CEA SURGERY. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS PRODUCT AND THE INDEX PROCEDURE. THERE WAS PRESENCE OF BABINSKI. THE EVENT WAS NOT RELATED TO A SPECIFIC SIDE OF THE BRAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED FOR THE 1ST SEIZURE, IT IS UNKNOWN IF IT WAS RELATED TO A SPECIFIC SIDE OF THE BRAIN, BUT THE EEG REPORT FOR ASSESSMENT OF FIRST STROKE STATED, "SIGNIFICANT FOR MODERATE SLOWING OF THE BACKGROUND OVER LEFT HEMISPHERE WITH COULD BE RELATED TO PREVIOUS KNOWN INFARCT IN THAT REGION, HOWEVER IT COULD BE POSTICAL IN NATURE." FOR THE 2ND SEIZURE, THE PATIENT HAD BEEN DRAGGING HIS RIGHT SIDE MORE THAN USUAL. IT IS UNKNOWN WHAT CAUSED THE 1ST SEIZURE (IT WAS A NEW ONSET). THE PATIENT HAD STOPPED HIS SEIZURE MEDICATION ABOUT 1 MONTH BEFORE THE 2ND SEIZURE. THE PATIENT HAS A HISTORY OF MULTIPLE CVA.

    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 14093102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R ANGIOGUARD RX