BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1032768 · Received April 22, 2008

    Report

    Report Number
    9616099-2008-01065
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    January 8, 2008
    Report Date
    March 13, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    FOLLOWING A CAROTID STENTING PROCEDURE, THE PT SUFFERED AN ISCHEMIC STROKE. THE PT IS A MALE WHO WAS ENROLLED IN THE SAPPHIRE STUDY. THE INDEX PROCEDURE WAS COMPLETED IN 2008, AND PT WAS ASYMPTOMATIC. THE TARGET LESION LOCATION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION OF THE CONTRALATERAL CAROTID ARTERY. REFERENCE VESSEL DIAMETER WAS 5MM. TARGET LESION DIAMETER STENOSIS WAS 90% WITH LESION LENGTH 25MM. TOTAL LENGTH OF STENTED SEGMENT WAS 40MM. LESION CALCIFICATION AND VESSEL TORTUOSITY WERE DESCRIBED AS MODERATE. PRE-DILATATION OF THE LESION WAS PERFORMED. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS USED, DEPLOYED, AND RETRIEVED SUCCESSFULLY WITH NO TECHNICAL PROBLEMS. IT IS UNKNOWN IF THERE WAS 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. POST-PROCEDURE MEDICATIONS WERE ASPIRIN AND CLOPIDOGREL. THE PROCEDURE WAS COMPLETED. THE PT LEFT THE ANGIO SUITE NEUROLOGICALLY INTACT. ON THE SAME DAY, AFTER THE PROCEDURE, THE PT SUFFERED A NEUROLOGICAL DEFICIT DESCRIBED AS APHASIA AND REFLEX CHANGE. THE PT ALSO SUFFERED HEMIATAXIA ON THE LEFT SIDE. THE ORIGINAL DIAGNOSIS WAS TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET WAS SUDDEN. ADDITIONAL INFO WAS REC'D STATING THAT THE PT SUFFERED A POST-PROCEDURE STROKE. THE PT WAS DISCHARGED 20008, AND PLACED IN A REHABILITATION FACILITY FOR A FEW WEEKS WHERE HE DID VERY WELL. THE PT HAS BEEN DISCHARGED HOME AND IS USING A WALKER TO GET AROUND THE HOUSE. THE PT IS NEARLY BACK TO BASELINE WITH GREATER THAN 95% RESOLUTION SINCE THE CAROTID STENTING PROCEDURE. THE PT DENIES ANY NEW SYMPTOMS SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13265470

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| H UNK.