BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 2997332 · Received March 6, 2013

    Report

    Report Number
    3001845648-2013-00022
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ZILVER PTX DEVICES FOR LOT NUMBER C801273 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE WAS NOT AVAILABLE FOR EVAL, AS THE STENT WAS IMPLANTED IN THE PT. IMAGES RELATED TO THIS INCIDENT HAVE BEEN REQUESTED BUT HAVE NOT YET BEEN PROVIDED. TO REDUCE THE RISK OF STENT THROMBOSIS WHEN USING ZILVER PTX DEVICES, DUAL ANTIPLATELET THERAPY (DAPT) IS RECOMMENDED. IT IS RECOMMENDED TO COMMENCE ADMINISTERING THIENOPYRIDINE-TYPE ANTIPLATELET DRUG AND ASPIRIN TO PTS FROM 24 HOURS BEFORE THE PROCEDURE, OR TO ADMINISTER A LOADING DOSE DURING THE PROCEDURE. IN ADDITION, TO ADMINISTER ASPIRIN INDEFINITELY, AND TO ADMINISTER THIENOPYRIDINE-TYPE ANTIPLATELET DRUG FOR AT LEAST 60 DAYS FOLLOWING THE PROCEDURE. IT MAY BE NOTED THAT ACCORDING TO FEEDBACK RECEIVED DAPT HAD BEEN CONDUCTED PROPERLY SINCE BEFORE THE PROCEDURE, AS THE PT HAD A PREVIOUSLY PLACED STENT IN ILIAC ARTERY. THERE IS LIMITED INFO AVAILABLE IN RELATION TO PT'S PRE-EXISTING CONDITIONS, THEREFORE IT CANNOT BE DETERMINED IF THE PT HAD ANY OTHER POTENTIAL RISK FACTORS FOR THROMBOSIS. THERE MAY HAVE BEEN ANATOMICAL FACTORS INVOLVED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE COMPLAINT INFO PROVIDED INDICATED THAT THE PT WAS NOT SUFFERING WITH THROMBOTIC DISEASE. IT WAS ALSO INDICATED THAT A POSSIBLE CAUSE OF THIS EVENT MIGHT BE THAT IT TOOK 7 AND A HALF HOURS TO COMPLETE THE PROCEDURE. IT MAY BE NOTED THAT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EFFECT AS PER INSTRUCTION FOR USE IFU0063-3. A HEALTH RISK ASSESSMENT WAS INITIATED FOR STENT THROMBOSIS AND THE RISK IS DEEMED TO BE LOW. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. CUSTOMER QA WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AFTER PRE-DILATION WITH A BALLOON, 3 ZILVER PTX STENTS WERE PLACED IN THE LESION; A ZIV6-35-125-6.0-120-PTX, A ZIV6-35-125-6.0-120-PTX AND A ZIV6-35-125-6.0-60-PTX (THIS COMPLAINT). POST DILATION WAS PERFORMED WITH A BALLOON, BUT CONFIRMATORY ANGIOGRAPHY CONFIRMED THAT THE BLOOD FLOW WAS NOT SO GOOD. THEREFORE, RE-DILATION WAS CONDUCTED WITH THE SAME BALLOON. HOWEVER, CONFIRMATORY ANGIOGRAPHY AFTER THAT REVEALED AN OCCLUSION DUE TO ACUTE IN-STENT THROMBOSIS IN THE WHOLE PTX STENTS PLACED. ASPIRATION OF THE THROMBOSIS WAS CONDUCTED WITH T-VAC(NIPRO) AND THEN, DILATION WITH THE SAME BALLOON (RIVAL 6MM 15CM) WAS PERFORMED. ANGIOGRAPHY CONFIRMED THAT THE FLOW WAS NOT SO GOOD, HOWEVER, SINCE IT WAS CONFIRMED THAT THERE REMAINED NO THROMBOSIS, THE PROCEDURE WAS ENDED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95037 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU COATED SELF EXPANDING VASCULAR STENTS NIU COOK IRELAND LTD C801273

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention