BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 11527505 · Received March 19, 2021

    Report

    Report Number
    3001845648-2021-00225
    Event Type
    Injury
    Date Received
    March 19, 2021
    Report Date
    January 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S006. DEVICE EVALUATION: THE ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT DEVICE (ZFV6) OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0073-3). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IT IS KNOWN THE PATIENTS SUFFERED WITH SYMPTOMATIC PERIPHERAL ARTERY DISEASE OF THE FEMOROPOPLITEAL AXIS. ALSO, THE BASELINE CHARACTERISTICS INCLUDED CONTENTIVE HEART FAILURE, CHRONIC KIDNEY DISEASE, CRITICAL LIMB-THREATENING ISCHEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CEREBROVASCULAR DISEASE ISCHEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CEREBROVASCULAR DISEASE, DIABETES MELLITUS, HYPERLIPIDAEMIA, HYPERTENSION, ISCHEMIC HEART DISEASE AND SOME WERE SMOKERS. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE PATIENTS PRE-EXISTING CONDITIONS. IT SHOULD ALSO BE NOTED THAT ¿AMPUTATION¿ IS LISTED AS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR IN THE INSTRUCTIONS FOR USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER ALL (B)(4) REQUIRED AMPUTATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S006. ANNEX G: G04122 - STENT. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    MATHLOUTHI 2020, ZILVER FLEX, INCREASED MORTALITY WITH PACLITAXEL-ELUTING STENTS IS DRIVEN BY LESION LENGTH. A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS OF 296 PATIENTS WHO UNDERWENT FPA STENTING BETWEEN JANUARY 2011 AND DECEMBER 2017 WAS PERFORMED. PATIENTS WERE GROUPED INTO BMS AND PES GROUPS. THE PRIMARY END POINT WAS ALL-CAUSE MORTALITY. SECONDARY END POINTS INCLUDED LIMB SALVAGE, PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY. A COMPARISON BETWEEN THE TWO GROUPS WITHIN TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II SUBGROUPS WAS ALSO PERFORMED. AMONG 296 PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENTING, THERE WERE NO DIFFERENCES IN THE 2-YEAR LIMB SALVAGE, PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY BETWEEN THE PACLITAXEL-ELUTING STENT (PES) AND THE BAREMETAL STENT GROUPS. THIS COMPLAINT IS CAPTURING 15 CASES WHERE LIMB SALVAGE WAS NOT POSSIBLE IN THE BARE METAL STENT (BMS) GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426333 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Disability