BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 3958903 · Received June 25, 2014

    Report

    Report Number
    3001845648-2014-00111
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT IS REPORTABLE BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR 'STENT FRACTURE' REGARDLESS OF PATIENT OUTCOME. THERE WERE NO ZIV6-35-125-7-80-PTX (ZILVER PTX) DEVICES OF LOT NUMBER C971825 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ZILVER PTX DEVICE OF LOT NUMBER C971825 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. IMAGES HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE COMPLAINT INFORMATION INDICATED THAT THE PATIENT AHS A LOT OF DISEASE IN THIS LEG. THE FOLLOWING COMMENTS WERE ALSO PROVIDED: "THE STENT FRACTURED UPON DEPLOYMENT; HOWEVER, THE PHYSICIAN SAID THAT HE WAS NOT HAPPY WITH THE INITIAL PLACEMENT AND DRAGGED THE STENT. THE PHYSICIAN BELIEVES THAT THE STENT FRACTURED DUE TO THE WAY IT WAS DRAGGED." STENT FRACTURE IN THIS OCCURRENCE MAY BE ATTRIBUTED TO THE USER TECHNIQUE DURING THE PROCEDURE. AS PER THE PRECAUTIONS IN THE INSTRUCTIONS FOR USE: "THE STENT IS NOT DESIGNED FOR REPOSITIONING OR RECAPTURING." AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IMAGES HAVE NOT YET BEEN PROVIDED, A DEFINITIVE ROOT CAUSE OF THE STENT FRACTURE COULD NOT BE DETERMINED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. AS PER INSTRUCTIONS FOR USE STENT STRUT FRACTURE IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES HAVE NOT YET BEEN PROVIDED, THE COMPLAINT IS CONFIRMED ON CUSTOMER TESTIMONY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE STENT FRACTURED UPON DEPLOYMENT; HOWEVER, THE PHYSICIAN SAID THAT HE WAS NOT HAPPY WITH THE INITIAL PLACEMENT AND DRAGGED THE STENT. THE PHYSICIAN BELIEVES THAT THE STENT FRACTURED DUE TO THE WAY IT WAS DRAGGED. THE FIRST HALF OF THE STENT WAS DEPLOYED WHERE THEY WANTED IT. THE SECOND HALF OF THE STENT LANDED MORE PROXIMAL TO THE INTENDED TARGET SITE. ANOTHER STENT WAS PLACED TO TACK DOWN THE SECOND SECTION THAT LANDED MORE PROXIMAL IN THE ILIAC. THE PHYSICIAN CONFIRMED ILIAC STENTS WERE INTENDED TO BE PLACED DURING THIS PROCEDURE ANYWAY. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369919 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C971875

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK