BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1053100 · Received May 22, 2008

    Report

    Report Number
    9616099-2008-01377
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 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
    AL, 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 # 1016427-2008-00153 AND 9616099-2008-01377.

    Description of Event or Problem · 1

    FOLLOWING POST-DILATION OF THE STENT BLOOD FLOW WAS SLOWED BY DEBRIS, WHICH WAS CAUGHT IN THE FILTER BASKET. THE PATIENT STARTED TO DEVELOP APHASIA AND RIGHT-SIDED HEMIPARESIS. A MALE PATIENT WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON THE NEXT DAY, AND PATIENT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. THE VESSEL WAS DESCRIBED AS MODERATELY CALCIFIED AND TORTUOUS. THE RATE OF STENOSIS WAS 90%. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION. PRE-DILATATION OF THE LESION WAS PERFORMED. A PRECISE STENT WAS IMPLANTED FOR TREATMENT OF THE TARGET LESION AND THEN POST-DILATED. THERE WAS NO MALFUNCTION WITH THE STENT. FOLLOWING POST-DILATION OF THE STENT BLOOD FLOW WAS SLOWED BY DEBRIS, WHICH WAS CAUGHT IN THE FILTER BASKET. THE PATIENT STARTED TO DEVELOP APHASIA AND RIGHT-SIDED HEMIPARESIS. THE PHYSICIAN THEN INSERTED AN ASPIRATION CATHETER AND SUCTIONED THE DEBRIS FROM THE FILTER AND BLOOD FLOW RETURNED TO NORMAL. THE APHASIA RESOLVED AND THE RIGHT-HANDED WEAKNESS RETURNED TO BASELINE. THE PROCEDURE WAS COMPLETED. POST-PROCEDURE MEDICATION WAS ASPIRIN AND CLOPIDOGREL. THE PATIENT LEFT THE ANGIO SUITE NEUROLOGICALLY INTACT. THE PATIENT WAS DISCHARGED ON TWO DAYS LATER, WITH CLOPIDOGREL AND ASPIRIN DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13093560

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R ASPIRATION CATHETER