BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1111922 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01948
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 16, 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
    JA
    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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT #1016427-2008-00211 AND 961609-2008-01948.

    Description of Event or Problem · 1

    AFTER POST-DILATATION OF A STENT THAT WAS PLACED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), THE BLOOD FLOW WAS STOPPED NEAR THE FILTER BASKET. THE PHYSICIAN SUCTIONED THE BLOOD FROM THE BASKET AND THE BLOOD FLOW RECOVERED. IMMEDIATELY AFTER THE PROCEDURE, THE PT HAD STROKE SYMPTOMS INCLUDING PARALYSIS. A POST PROCEDURE ANGIOGRAM WAS PERFORMED AD REVEALED A CEREBRAL INFARCTION. THE PT IS A MALE. THE TARGET LESION WAS MILDLY CALCIFIED, NOT TORTUOUS. THE RATE OF STENOSIS WAS 54%. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE. THERE WAS NO DIFFICULTY ACCESSING THE LESION OR POSITIONING THE ANGIOGUARD IN THE VESSEL DISTAL TO THE LESION. THE LESION WAS PRE-DILATED. THERE WAS NO DIFFICULTY PLACING THE STENT. IT IS UNK WHAT BALLOON WAS USED FOR POST-DILATION. THE PHYSICIAN BELIEVES THAT THE DEBRIS IN THE FILTER BASKET IS WHAT CAUSED THE SLOW BLOOD FLOW. THE SYMPTOMS OF STROKE APPEARED AFTER THE FILTER BASKET WAS REMOVED FROM THE PT. THE PHYSICIAN BELIEVES THAT DEBRIS FLOWED TO THE DISTAL VESSEL AFTER REMOVAL OF THE BASKET. THE PT WAS TREATED WITH ANTICOAGULATION AND IS BEING CLOSELY MONITORED. THE PT HAS RESIDUAL PARALYSIS.

    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 13285619

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R SUCTION CATHETER: EXPORT (MEDTRONIC)