BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1021288 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00781
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE SAME PRODUCT DISTRIBUTED IN THE UNITED STATES. PLEASE NOTE THAT PATIENT CODE REPRESENTS TEMPORARY LEFT HEMIPLEGIA. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT REPORTED UNDER MANUFACTURING NUMBERS 9616099-2008-00781 AND 1016427-2008-00083. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT INDICATED A PATIENT EXPERIENCED HYPOPERFUSION AFTER POST DILATATION DURING IMPLANTATION OF A PRECISE SELF EXPANDING STENT. THE TARGET LESION WAS AN UNKNOWN CAROTID. NO INFORMATION REGARDING THE VESSEL/LESION CHARACTERISTICS IS AVAILABLE. AFTER IMPLANTATION OF THE PRECISE STENT, BLOOD FLOW WAS NORMAL. HOWEVER, AFTER POST DILATATION, SLOW FLOW WAS NOTED. FLOW RETURNED TO NORMAL AFTER THE ANGIOGUARD BASKET WAS SUCTIONED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A TEMPORARY HYPOTENSION AND HEMIPLEGIA ON THE LEFT SIDE OF THE BODY DURING THE PROCEDURE. THE PATIENT WAS ANTI COAGULATED; MEDICATIONS ARE UNKNOWN. THE PATIENT ACHIEVED FULL RECOVERY BEFORE RETURNING TO THE WARD. NO RESIDUAL EFFECTS WERE NOTED AND THE PATIENT WAS IN STABLE CONDITION. IT IS SUSPECTED THAT DEBRIS ACCUMULATION IN THE ANGIOGUARD BASKET MAY HAVE CAUSE THE SLOW FLOW AS FLOW RESUMED TO NORMAL AFTER IT WAS SUCTIONED.

    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 81 YR Required Intervention ANGIOGUARD: 603014MC| LOT 71007509