BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1873124 · Received October 18, 2010

    Report

    Report Number
    9616099-2010-00802
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 23, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE EMAIL 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 PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION DURING THE STUDY PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. AT THE ONE YEAR FOLLOW-UP CONTACT, THE PATIENT REPORTED HAVING AN ADVERSE EVENT OF CAROTID REVASCULARIZATION. THE PATIENT EXPERIENCED VERY LATE THROMBOSIS OF THE PREVIOUSLY IMPLANTED PRECISE 8 X 40 STENT. THE VERY LATE THROMBOSIS WAS TREATED BY IMPLANTATION OF ANOTHER STENT. AT INDEX THE PROCEDURE, THE ASYMPTOMATIC (B)(6) FEMALE HAD A HISTORY OF HYPERLIPIDEMIA, SMOKING, DIABETES MELLITUS, AND HYPERTENSION. THE PROXIMAL LICA TARGET LESION WAS REPORTED TO BE: 22 MM LENGTH, A 90% STENOSIS, ABSENT OF THROMBUS, 5.0 MM VESSEL DIAMETER, MILDLY CALCIFIED, NOT TORTUOUS, AND ULCERATED. A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. THE LESION WAS PRE-DILATED WITH NO DOCUMENTED RESISTANCE. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE INTENDED TARGET LESION. THE RESIDUAL STENOSIS WAS 0%. DISCHARGE NIH AND RANKIN STROKE SCALE SCORES WERE 0. ANTIPLATELET THERAPY INCLUDED PRE AND POST PROCEDURE AND DISCHARGE ASPIRIN AND CLOPIDOGREL. STROKE SCORE SCALES WERE UNCHANGED AT THIRTY DAY FOLLOW-UP WITH INDICATION THAT MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL AND NO ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED IN RESPONSE TO MULTIPLE INVESTIGATIVE EFFORTS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. A DHR REVIEW WAS REQUESTED TO (B)(4), FOR PART NUMBER: 23544 AND STENT LOT NUMBERS 505630, 505661, 505663 AND 505631; AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. 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 14136793 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. THROMBOSIS IN DEVICE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE PATIENT WAS PRESCRIBED ASA AND PLAVIX REGIMEN AS PER THE IFU. PATIENT COMPLIANCE AND EFFECTIVENESS OF THE PRESCRIBED ASPIRIN AND PLAVIX REGIMEN IS NOT KNOWN. BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE; HOWEVER, VESSEL, LESION, AND PATIENT FACTORS MAY HAVE CONTRIBUTED. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE EMAIL 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 PROXIMAL LEFT INTERNAL CAROTID ARTERY (LICA) TARGET LESION DURING THE STUDY PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. AT THE ONE YEAR FOLLOW-UP CONTACT, THE PATIENT REPORTED HAVING AN ADVERSE EVENT OF CAROTID REVASCULARIZATION. THE PATIENT EXPERIENCED VERY LATE THROMBOSIS OF THE PREVIOUSLY IMPLANTED PRECISE 8 X 40 STENT. THE VERY LATE THROMBOSIS WAS TREATED BY IMPLANTATION OF ANOTHER STENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE PATIENT WAS ASYMPTOMATIC AT THE INDEX PROCEDURE. THE PROXIMAL LICA TARGET LESION WAS REPORTED TO BE: 22 MM LENGTH, A 90% STENOSIS, ABSENT OF THROMBUS, 5.0 MM VESSEL DIAMETER, MILDLY CALCIFIED, NOT TORTUOUS, AND ULCERATED. THE LESION WAS NOT PRE-DILATED. A 5 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE. A PRECISE 8 X 40 STENT WAS SUCCESSFULLY IMPLANTED AT THE INTENDED TARGET LESION. THE RESIDUAL STENOSIS WAS 0%.

    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 14136793

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R ANGIOGUARD 5 MM EMBOLIC PROTECTION DEVICE