BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 15758856 · Received November 9, 2022

    Report

    Report Number
    3001845648-2022-00757
    Event Type
    Injury
    Date Received
    November 9, 2022
    Report Date
    February 8, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER FLEX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE THE KNEE POPLITEAL ARTERY¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS 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 OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY AND ABOVE-THE-KNEE POPLITEAL ARTERY HOWEVER FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE DEVICE WAS USED IN A CRURAL VESSEL. THE OFF-LABEL USE MAY HAVE CAUSED OR CONTRIBUTED TO THE EMBOLISM FORMATION AS IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF ITS INTENDED USE. IT SHOULD ALSO BE NOTED THAT EMBOLISM IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER TORRES-BLANCO ET AL ¿MID-TERM OUTCOMES OF ENDOVASCULAR TREATMENT FOR TASC-II D FEMOROPOPLITEAL OCCLUSIVE DISEASE WITH CRITICAL LIMB ISCHEMIA¿. ACCORDING TO THE INITIAL REPORTER, 01 PATIENT WAS TREATED WITH FIBRINOLYSIS AS A RESULT OF A CRURAL EMBOLIZATION. AS PER MEDICAL ADVISOR INPUT THIS WAS AN UNEXPECTED MEDICAL INTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    TORRES BLANCO ET AL 2016: (ZILVER FLEX) "MID-TERM OUTCOMES OF ENDOVASCULAR TREATMENT FOR TASC-II D FEMOROPOPLITEAL OCCLUSIVE DISEASE WITH CRITICAL LIMB ISCHEMIA" ACCESS TO THE LESION WAS ACHIEVED VIA THE COMMON FEMORAL ARTERY THROUGH A CONTRALATERAL RETROGRADE APPROACH AS THE PREFERRED ACCESS. LESIONS WERE CROSSED WITH 0.035-INCH OR 0.018-INCH WIRES AND 4F OR 5F HYDROPHILIC CATHETERS. PREDILATATION WAS ROUTINELY PERFORMED. STENTING WAS ROUTINELY PERFORMED IN ALL PATIENTS WITH SFA OCCLUSIONS. IN CASES OF SEVERAL STENTS, THESE WERE OVERLAPPED BY 1 CM, TRYING TO USE AS FEW AS POSSIBLE. STENTS UTILIZED WERE NITINOL SELF-EXPANDING OR PTFE-COVERED STENTS, AND THE SELECTED TYPE WAS DETERMINED BY AVAILABLE INVENTORY AND OPERATOR PREFERENCE. POSTDILATION WAS PERFORMED WHEN THERE WAS INADEQUATE ANGIOGRAPHIC OUTCOME. OFF LABEL USE: TO CAPTURE THE USE OF THE DEVICE IN CRURAL VESSELS WHICH RESULTED IN ONE CRURAL EMBOLIZATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 08-FEB-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949293 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention