BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 15112430 · Received July 27, 2022

    Report

    Report Number
    3001845648-2022-00478
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    November 26, 2020
    Report Date
    November 25, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. 510K P050017/S006. PRODUCT CODE: NIO.

    Additional Manufacturer Narrative · 0

    510K P050017/S006. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO PR 370583 (3001845648-2022-00479) DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER FLEX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058) LISTS RESTENOSIS OF THE STENTED ARTERY AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS AND/OR KNOWN POTENTIAL COMPLICATIONS. FROM THE ARTICLE IT IS KNOW THAT THE PATIENTS RISK FACTORS FOR RESTENOSIS/OCCLUSION INCLUDED LONG HISTORY OF SMOKING, ARTERIAL HYPERTENSION, DIABETES MELLITUS, HYPERLIPOPROTEINEMIA, CHRONIC RENAL FAILURE, CRITICAL LIMB ISCHEMIA AND TASC II D LESIONS. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS OF THE STENTED ARTERY AS A POTENTIAL ADVERSE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER YISHENG LIN ET AL ¿MID-TERM OUTCOMES OF ENDOVASCULAR TREATMENT AND RISK FACTORS FOR RECURRENCE IN PATIENTS WITH TRANS-ATLANTIC-INTER-SOCIETY II C/D FEMOROPOPLITEAL LESIONS¿. ACCORDING TO THE INITIAL REPORTER, 31 PATIENTS EXPERIENCE RESTENOSIS OR REOCCLUSION REQUIRING INTERVENTION. AS PER MEDICAL ADVISOR INPUT ¿REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE PATIENTS IN THIS STUDY RECEIVED SELF-EXPANDING STENTS, OF WHICH 64 WERE BARE METAL STENTS (B)(6) INC., (B)(6); ZILVER FLEX, COOK MEDICAL, (B)(4) WITH SOME STENT GRAFTS (VIABAHN; GORE MEDICAL, FLAGSTAFF, AZ, USA). ONCE THE GUIDEWIRE CATHETER HAD PASSED THROUGH THE TRUE VASCULAR CAVITY, A PERCUTANEOUS DIRECTIONAL ATHERECTOMY WAS PERFORMED (SEE FIGURE 5). A PERIPHERAL PLAQUE EXCISION SYSTEM (SILVERHAWK OR TURBOHAWK) WAS USED TO CUT THROUGH THE ENTIRE LESION ALONG THE PRECEDING 0.035 CM GUIDE WIRE, WHICH WAS PASSED THROUGH THE OCCLUDED SEGMENT INTO THE DISTAL OUTFLOW TRACT USING THE EXCHANGE TECHNIQUE. GUIDED BY THE ROADMAP, THE CUTTING EDGE WAS AIMED AT THE SCLEROSIS PLAQUE AND PUSHED TO EXCISE THE PLAQUE SLOWLY AND UNIFORMLY. 31 PATIENTS WERE DIAGNOSED WITH >50% RESTENOSIS OR RE-OCCLUSION.EVT WAS REPEATED ON THE 24 AFFECTED LIMBS OF THESE PATIENTS.EIGHT CASES OF RESTENOSIS WERE RECANALIZED BY BALLOON DILATION, AND 13 CASES WERE RECANALIZED BY BALLOON DILATION AND STENT IMPLANTATION. FOUR OF THE PATIENTS IN OUR STUDY WERE SUCCESSFULLY RECANALIZED WITH PERCUTANEOUS DIRECTIONAL ATHERECTOMY DEVICES. ONLY 1 PATIENT REQUIRED AN ADDITIONAL STENT IMPLANTATION. **FILE WILL CAPTURE A POTENTIAL OF 31 CASES RESTENOSIS / REOCCLUSION WITH INTERVENTION ¿ UNCONFIRMED HOW MANY ZILVER FLEX STENTS WERE INVOLVED **

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-NOV-2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943546 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention