BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 2960868 · Received February 11, 2013

    Report

    Report Number
    3001845648-2013-00013
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MAF
    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 OF LOT NUMBER C780932 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE STENT REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR EVALUATION. THE IMAGES RELATED TO THIS COMPLAINT WERE NOT PROVIDED. THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM THE CUSTOMER'S COMPLAINT. IT MAY BE NOTED THAT THE PATIENT HAD A KNOWN POTENTIAL RISK FACTOR FOR THROMBOSIS - DIABETES. THIS PRE EXISTING CONDITION POTENTIALLY COULD HAVE RESULTED IN OCCLUSION AFTER THE STENT PLACEMENT. INFORMATION PROVIDED ALSO INDICATED THE PATIENT INVOLVED HAD THE FOLLOWING PRE-EXISTING CONDITIONS: SEVERE LOWER LIMB ISCHEMIA AND A BRAIN INFARCTION (WHEN THE PATIENT WAS 50 YEARS OLD). IT MAY BE NOTED THE PHYSICIAN INVOLVED IN THIS COMPLAINT HAS STATED THAT A POSSIBLE CONTRIBUTING CAUSE OF THIS COMPLAINT MAY BE ATTRIBUTED TO THE FOLLOWING: "SINCE THE ACUTE THROMBOEMBOLIC OCCLUSION WAS OBSERVED NOT IN THE AREA WHERE THE PTXS HAD BEEN PLACE, BUT AROUND THE AREA BETWEEN DISTAL END OF THE LEFT SFA AND THE BEGINNING OF THE LEFT POPLITEAL ARTERY (WHERE THE HIGH GRADE STENOSIS EXISTED ORIGINALLY), I THINK THAT THE CAUSE OF THIS OCCLUSION IS NOT PTX BUT THE WIRE GUIDE/MANIPULATION OF THE WIRE GUIDE". FURTHER INFORMATION FROM THE PHYSICIAN INVOLVED STATED THAT EVEN THOUGH HE DOES NOT THINK ZILVER PTX STENTS CAUSED THE THROMBOEMBOLIC OCCLUSION, HE ALSO THINKS THAT "IT CANNOT BE DENIED COMPLETELY THAT PTX STENTS MIGHT HAVE MADE SOME EFFECT TO THIS EVENT." 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 - THE OVERALL RISK LEVEL WAS 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 MANUFACTURING RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR PTA IN LEFT SFA. THE PROCEDURE WAS CONDUCTED AS LABELED. THERE WAS A TOTAL OCCLUSION (APPROXIMATELY 3~4 CM) IN LEFT SFA. A HIGH GRADE STENOSIS (APPROXIMATELY 90%) ALSO EXISTED AROUND THE AREA BETWEEN DISTAL END OF THE LEFT SFA AND THE BEGINNING OF THE LEFT POPLITEAL ARTERY. DEBRIDEMENT OF LEFT HALLUX WAS PLANNED AFTER THE PTA. UNDER THE US ECHO, THE LEFT ADDUCTOR CANAL WAS PUNCTURED. THE LEFT SFA WAS EXPOSED BY ADHESION AND PUNCTURED THEN. THE TOTAL OCCLUSION IN LEFT SFA WAS PASSED THROUGH WITH A KMP CATHETER AND A WIRE GUIDE (RADIFOCUS/TERUMO) AND AFTER THA, THE WIRE GUIDE WAS CHANGED TO A STIFF ONE (AMPLATX SUPER STIFF 0.035INCH 260CM/BSJ). A 6.0-60 PTX ((B)(4)) WAS PLACED THERE OVER THE WIRE GUIDE. SINCE THE PROXIMAL PART OF THE DEPLOYED PTX DID NOT EXPAND FULLY, POST DILATION WITH A BALLOON (WANDA 4.0X20/ BSJ) WAS PERFORMED. A 6.0-40 PTX ((B)(4)) WAS PLACED NEXT AND POST DILATION WITH A BALLOON (WANDA 5.0X40/BSJ) WAS CONDUCTED. CONFIRMATORY ANGIOGRAPHY CONFIRMED ACUTE THROMBOEMBOLIC OCCLUSION AROUND THE AREA BETWEEN DISTAL END OF THE LEFT SFA AND THE BEGINNING OF THE LEFT POPLITEAL ARTERY. (MEANING THAT THE OCCLUSION WAS OBSERVED NOT IN THE AREA WHERE THE TWO PTXS HAD BEEN PLACED IN, BUT DISTAL TO THERE). REMOVAL OF THE THROMBOSIS WITH THROMBUSTER 2 (MANUFACTURED BY KANEKA) WAS CONDUCTED, BUT IT COULD NOT BE REMOVED WELL. THEREFORE, A NEW 6.0-60 PTX WAS PLACED IN THE THROMBOEMBOLIC OCCLUSION AND THE PROCEDURE WAS ENDED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60073 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT COATED SELF EXPANDING VASCULAR STENTS MAF COOK IRELAND LTD C780932

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R