BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 3971225 · Received July 8, 2014

    Report

    Report Number
    3001845648-2014-00119
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    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

    PMA/510(K)#: P100022/S001. ADDITIONAL STENT INVOLVED IN THIS COMPLAINT EVENT (ZIV6-35-125-6.0-100-PTX) WILL BE SUBMITTED IN AN ADDITIONAL REPORT, REF # 3001845648-2014-00118. THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION CARRIED OUT DUE TO THE OCCURRENCE OF THROMBOSIS WHILE A ZILBER PTX STENT WAS INDWELLING. 'THE PROCEDURE HAS BEEN REVEALED TO HAVE BEEN CONDUCTED BY IPSILATERAL ANTEGRADE APPROACH FROM "RIGHT SFA." AT FIRST, THE PHYSICIAN PLANNED TO TREAT THE RIGHT SFA LESION ONLY WITH POBA. THUS, THE RIGHT SFA WAS DIRECTLY PUNCTURED AND A GUIDING SHEATH WAS ADVANCED FROM THERE; HOWEVER, DURING INSERTION OF THE GUIDING SHEATH, DISSECTION IN THE LESION OCCURRED. PTX STENTS PLACEMENT WAS THEREFORE CONDUCTED AS COUNTERMEASURE AGAINST IT. THE DELIVERY SYSTEMS OF THE USED TWO PTX WERE ADVANCED THROUGH THE GUIDING SHEATH ADVANCED FROM RIGHT SFA.' THERE WAS NO ZILVER PTX DEVICE OF LOT NUMBER C942145 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE STENT WAS IMPLANTED IN THE PATIENT; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE REQUESTED RELATING TO THIS COMPLAINT BUT HAVE NOT BEEN RECEIVED TO DATE. THE BELOW LIST INDICATES POTENTIAL RISK FACTORS THAT CAN GENERALLY CONTRIBUTE TO THE THROMBOSIS EVENT: PATIENT FACTORS - HISTORY OF COAGULOPATHY/PRIOR THROMBOSIS (E.G. DVT), DIABETES, ESPECIALLY IF POORLY CONTROLLED, CANCER/CHEMOTHERAPY, ADVANCED AGE, OBESITY, HYPERLIPIDEMIA, HYPERTENSION, SMOKING. LESION FACTORS - LONG LESION, SMALL VESSEL DIAMETER, SEVER CALCIFICATION, LESION TOTALLY OCCLUDED PRIOR TO STENT PLACEMENT, PLACEMENT FOR IN STENT RESTENOSIS. PROCEDURE FACTORS - RESIDUAL INFLOW, OUTFLOW OR IN-SEGMENT STENOSIS OR DISSECTION, POOR RUN OFF (I.E. BEYOND TRIFURCATION). MEDICATION FACTORS - INADEQUATE PROCEDURAL HEPARINIZATION, INADEQUATE LOADING CLOSE OF ANTIPLATELET (TICLOPIDINE OR CLOPIDOGREL), INADEQUATE DAPT PRESCRIBED, NON-RESPONDER TO THE APT, OR NON-COMPLIANT WITH PRESCRIBE REGIMEN. ACCORDING TO THE INFORMATION PROVIDED THE PATIENT HAD THE FOLLOWING KNOWN POTENTIAL RISK FACTORS FOR THROMBOSIS: SMOKER, CORONARY ARTERY DISEASE AND PULMONARY DISEASE WERE ALSO CONFIRMED. IT CAN BE NOTED THAT THE PATIENT WAS ON THE ANTI-PLATELET THERAPY PRIOR TO AND AFTER THE PROCEDURE; THEREFORE, MEDICATION FACTOR IS NOT A CONTRIBUTING FACTOR TO STENT THROMBOSIS IN THIS CASE. COMMENTS PROVIDED FOR BY THE PHYSICIAN INVOLVED IN THIS COMPLAINT WERE AS FOLLOWS: 'I ASSUME THIS THROMBOSIS OCCURRED DUE TO THE DISSECTION DURING PROCEDURE, ASTRICTION AND/OR RESIDUAL STENOSIS IN THE LESION (OUT OF WHERE STENTS WERE PLACED). IN ADDITION TO ABOVE, CONSIDERING THAT INCOMPLETE EXPANSION OF THE STENT WAS NOT OBSERVED, I DO NOT THINK THE CAUSE OF THIS EVENT IS PTX STENTS.' THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY; HOWEVER, AS PER THE ABOVE FEEDBACK IT CAN BE STATED THAT IT IS UNLIKELY THAT STENT THROMBOSIS OCCURRED DUE TO ZILVER PTX MALFUNCTION. A DEFINITIVE ROOT CAUSE OF THIS STENT THROMBOSIS CANNOT BE DETERMINED. AS PER INSTRUCTIONS FOR USE, ARTERIAL THROMBOSIS IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT 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 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) 2014, ONE ZIV6-35-125-6.0-100-PTX STENT AND ONE ZIV6-35-125-7.0-PTX STENT (THIS REPORT) WERE PLACED IN THE RIGHT SFA BY IPSILATERAL ANTEGRADE APPROACH. ALTHOUGH DISSECTION OF RIGHT SFA OCCURRED DURING THE PROCEDURE, THE PLACEMENT COULD BE COMPLETED SUCCESSFULLY. THE PATIENT HAD A FEELING OF STRANGENESS WHEN LEAVING THE HOSPITAL. ON (B)(6) 2014, THE PATIENT VISITED THE HOSPITAL CLAIMING PAIN IN HIS LOWER LIMB. SINCE THROMBOSIS WAS SUSPECTED, CT IMAGING WAS CONDUCTED, BUT THROMBOSIS COULD NOT BE CONFIRMED FROM THE CT IMAGES. ON (B)(6) 2014, ANGIOGRAPHY CONFIRMED THE THROMBOTIC OCCLUSION IN PTX STENTS. ASPIRATION OF THE BLOOD CLOTS WITH TVAC (MANUFACTURED BY NIPRO) WAS PERFORMED 5 TIMES AND AFTER THE CLOTS WERE SUCKED IN, LOW-PRESSURE LONG INFLATION WITH JACKAL 4*80 (MANUFACTURED BY KANEKA) WAS CONDUCTED; HOWEVER, THE FLOW DID NOT IMPROVE. THE LESION WAS THEREFORE DILATED WITH ANGIOSCULPT 5*40 (MANUFACTURED BY ANGIOSCORE) NEXT, FOLLOWED BY ANGIOGRAPHY, WHICH CONFIRMED THE IMPROVEMENT OF THE BLOOD FLOW AND THUS, THE PROCEDURE WAS ENDED. AFTER THE PROCEDURE, WARFARIN WAS ADMINISTERED TO THE PATIENT. SUBJECTIVE SYMPTOM OF THE PATIENT DISAPPEARED. THE PATIENT IS BEING MONITORED NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395789 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU COOK IRELAND LTD C942195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention