BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    MDR report key: 1900906 · Received November 10, 2010

    Report

    Report Number
    1820334-2010-00568
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 12, 2010
    Manufacturer
    COOK, INC.
    Product Code
    NIO
    PMA / PMN Number
    P050017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXP DATE UNK AS LOT IS UNK. DEVICE FAILURE FROM CRUSHED EDGES IS NOT LABELED. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THERE IS A GENERAL INSPECTION OF THE COMPLETED DEVICE. THERE IS NO EVIDENCE TO SUGGEST DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. WITHOUT AN EXAMINATION OF THE COMPLAINT DEVICE, WE CANNOT DETERMINE WITH ANY CERTAINTY. THE EVENT DESCRIPTION STATEMENT THAT "THE PATIENT WAS SEVERELY DISEASED BILATERALLY" LENDS CREDENCE TO THIS BEING PROCEDURALLY RELATED RATHER THAN THE DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE AREA REP RECEIVED A PHONE CALL FROM THE PHYSICIAN INVOLVED IN A ZILVER 518 RX VASCULAR SELF-EXPANDING STENT PLACEMENT THAT TOOK PLACE ON (B)(6) 2010. THE PHYSICIAN NORMALLY FOR ILLIACS AND WITH HIS PRIOR COMFORTABILITY ISSUES WITH THE ZILVER, PREFERS TO USE ANOTHER MFR'S STENTS. FOR THIS CASE, HE WANTED TO USE THE ZILVER BECAUSE IT WAS 5 FR COMPATIBLE AND THE PT WAS SEVERLY DISEASED BILATERALLY. HE WAS DOING A REVASCULARIZATION OF THE LEG GOING CONTRALATERAL. THE END RESULT WAS FINE WITH THE STENT PLACEMENT. THE NEXT DAY, HIS PARTNER WAS DOING A HEART CATH AND TRIED TO GO THROUGH THE STENTS AND WHEN THEY WENT TO RECROSS THROUGH THE STENTS WITH A 6 FR SHEATH, THE ZILVER EDGES WERE CRUSHED. THEY COULD NOT FINISH THE CASE AND THE PHYSICIAN HAS TO GO BACK IN AND REFIX THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 518 VASCULAR SELF-EXPANDING STENT NIO VASCULAR STENT NIO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1