BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4314843 · Received November 25, 2014

    Report

    Report Number
    3001845648-2014-00273
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    November 12, 2013
    Report Date
    October 28, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022 AND S001. UDI#: (B)(4). THIS REPORT RELATES TO 1XZIV6-35-125-6.0-120-PTX OF LOT# C780022. REFERENCE ALSO RELATED MDR REPORTS 3001845648-2014-00271 AND 3001845648-2014-00272. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION (THE STENT REMAINS IMPLANTED IN THE PATIENT). WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. TO DATE THE REVIEW OF IMAGES RELATING TO THIS EVENT HAS NOT BEEN RECEIVED. FROM THE COMPLAINT INFORMATION AND PATIENT'S PRE-EXISTING CONDITIONS IT IS KNOWN THAT THE PATIENT HAD KNOWN POTENTIAL RISK FACTORS FOR THROMBOSIS SUCH AS: HYPERTENSION, HYPERCHOLESTEROLEMIA AND RENAL FAILURE. IT IS VERY UNLIKELY THAT THROMBOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION; HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS STENT THROMBOSIS CANNOT BE DETERMINED. AS NO IMAGE REVIEW WAS AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION THE COMPLAINT IS CONFIRMED ON CUSTOMER TESTIMONY. IT MAY BE NOTED THAT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EFFECT OF THE USE OF THIS DEVICE. 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. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, TWO ZIV6-35-125-6.0-120-PTX AND ONE ZIV6-35-125-7.0-40-PTX WERE IMPLANTED IN THE RIGHT SFA OF THE PATIENT. DISSECTION OCCURRED AND WAS UNTREATED AT THAT TIME. ON (B)(6) 2013, ANGIOGRAPHY CONFIRMED THE THROMBOSIS AT THE LESION WHERE THE STENTS WERE PLACED. PATIENT SHOWED SYMPTOMS OF WORSENED CLAUDICATION, REST PAIN AND PERSISTENT CLAUDICATION. ON (B)(6) 2014 PTA AND STENT PLACEMENT FOR THROMBOSIS WERE PERFORMED. ON (B)(6) 2014, THERE HAVE BEEN NO FURTHER ADVERSE EFFECTS TO THE PATIENT REPORTED AS OCCURRING AS A RESULT OF THIS SPECIFIC EVENT. THIS REPORT RELATES TO 1X ZIV6-35-125-6.0-120-PTX OF LOT# C780022. REFERENCE ALSO RELATED MDR REPORTS 3001845648-2014-00271 AND 3001845648-2014-00272.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766054 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C780022

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention