BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1162749 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02254
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER THE CAROTID STENTING PROCEDURE, THE PT BECAME HYPOTENSIVE AND NEEDED TO BE TREATED WITH IV FLUIDS AND DOPAMINE. THIS FEMALE WITH KNOWN CORONARY ARTERY DISEASE AND CORONARY BYPASS GRAFTING IN EARLY 2008 WAS DIAGNOSED WITH A LEFT CAROTID STENOSIS. THE PT ELECTED TO UNDERGO STENT PLACEMENT RATHER THAN UNDERGO A CAROTID ENDARTERECTOMY. THE PT WAS ENROLLED IN THE STUDY. A SELECTIVE CAROTID ANGIOGRAM REVEALED A 70% STENOSIS IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS USED, DEPLOYED, AND RETRIEVED SUCCESSFULLY WITH NO TECHNICAL PROBLEMS. THERE WAS NO DEBRIS FOUND IN THE BASKET UPON RETRIEVAL OF THE ANGIOGUARD DEVICE. A PRECISE STENT WAS IMPLANTED FOR TREATMENT OF TARGET LESION. THERE WAS NO MALFUNCTION WITH THE STENT. THE PROCEDURE WAS COMPLETED. THE PT LEFT THE ANGIO SUITE NEUROLOGICALLY INTACT. AFTER THE PROCEDURE, THE PT BECAME HYPOTENSIVE AND WAS TREATED WITH IV FLUIDS AND DOPAMINE. THE PT WAS TRANSFERRED TO THE CORONARY INTENSIVE CARE UNIT AND WAS EVENTUALLY TAKEN OFF HER ANTI-HYPERTENSIVE MEDICATION AND WAS MAINTAINED ON IV FLUIDS AND DOPAMINE. THE PT'S PRESSURE RESPONDED AND SHE WAS SUCCESSFULLY WEANED OFF THE DOPAMINE, AND DID WELL. TWO DAYS AFTER THE PROCEDURE, THE PT SUFFERED FROM SHORTNESS OF BREATH. A BLOOD GAS WAS OBTAINED AND REVEALED THAT THE PT HAD CARBON DIOXIDE RETENTION DUE TO HER EMPHYSEMA AND DUE TO HER END-STAGE PULMONARY DISEASE. FOUR DAYS AFTER THE PROCEDURE, THE PT EXPIRED. THE CAUSE OF DEATH WAS CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND RESPIRATORY FAILURE. THE EVENT WAS DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

    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 13346693

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R