BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 11527520 · Received March 19, 2021

    Report

    Report Number
    3001845648-2021-00224
    Event Type
    Injury
    Date Received
    March 19, 2021
    Report Date
    June 16, 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 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. DOCUMENT REVIEW: 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 (IFU0058). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IT IS KNOWN 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 SMOKING. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENTS PRE-EXISTING CONDITIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, ALL 22 PATIENTS DIED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S006. (B)(4). 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. COMPARED WITH THE BMS GROUP, THE PES GROUP EXHIBITED SIGNIFICANTLY HIGHER RATES OF 2-YEAR ALL-CAUSE MORTALITY (23.9% VS 5.1%; P = .05; FIG). AFTER ADJUSTMENT FOR AGE AND OTHER POTENTIAL CONFOUNDERS, PES USE WAS ASSOCIATED WITH A TWOFOLD INCREASE IN ALL-CAUSE MORTALITY (ADJUSTED HAZARD RATIO, 2.3; 95% CI, 1.31-27; P = .02; TABLE V). THIS COMPLAINT IS CAPTURING ALL CAUSE MORTALITY IN 22 PATIENTS (11.4% OF 195 PATIENTS IN THE BMS GROUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426944 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 Death