BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1051652 · Received May 21, 2008

    Report

    Report Number
    9616099-2008-01366
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2008-01366 AND 1016427-2008-00152.

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING POST-DILATION OF THE STENT, THE PATIENT HAD WEAKNESS AND COULD NOT SQUEEZE WITH HER LEFT HAND. AN ANGIOGRAM REVEALED ABSENCE OF FLOW INTO THE MID INTERNAL CAROTID ARTERY (ICA). AN EXPORT CATHETER WAS USED TO ASPIRATE THE DEBRIS THAT HAD BEEN CAPTURED BY THE ANGIOGUARD FILTER BASKET. THERE WAS ALSO SOME SPASM OF THE MID TO DISTAL ICA, WHICH WAS TREATED WITH NITROGLYCERIN. THE PATIENT IS A FEMALE PATIENT WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON SIX DAYS LATER, AND THE PATIENT WAS ASYMPTOMATIC. THE TARGET LESION LOCATION WAS THE RIGHT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. TARGET LESION DIAMETER STENOSIS WAS 80%. LESION CALCIFICATION WAS MILD AND CONCENTRIC AND VESSEL TORTUOSITY WAS MILD. THE PHYSICIAN MADE ACCESS VIA THE RIGHT FEMORAL ARTERY. AN ARCH AORTOGRAM AND SELECTIVE CEREBRAL ARTERY ANGIOGRAM WAS PERFORMED. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS ADVANCED PASSED THE LESION IN THE CAROTID ARTERY AND DEPLOYED. PRE-DILATATION OF THE LESION WAS PERFORMED WITH A 4MM BALLOON. AN 8 X 30 STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION AND THE STENT WAS POST-DILATED WITH 5 X 20 BALLOON. IMMEDIATELY FOLLOWING POST-DILATION OF THE STENT THE PATIENT HAD WEAKNESS AND COULD NOT SQUEEZE WITH HER LEFT HAND. AN ANGIOGRAM REVEALED ABSENCE OF FLOW INTO THE MID INTERNAL CAROTID ARTERY (ICA). AN EXPORT CATHETER WAS USED TO ASPIRATE THE DEBRIS THAT HAD BEEN CAPTURED BY THE ANGIOGUARD FILTER BASKET. THE PHYSICIAN IMMEDIATELY REMOVED BASKET AND A FOLLOW-UP ANGIOGRAM SHOWED FLOW THROUGH THE INTERNAL CAROTID ARTERY WITH NO CHANGE TO PRE-STENT CEREBRAL FLOW. THERE WAS SOME SPASM OF THE MID TO DISTAL ICA, WHICH WAS TREATED WITH NITROGLYCERIN. THE SPASM RESOLVED. THE PATIENT WAS AT BASELINE NEUROLOGICALLY WHEN TAKEN FROM THE ANGIO SUITE. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON THE NEXT DAY.

    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 13365170

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R