BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 11527417 · Received March 19, 2021

    Report

    Report Number
    3001845648-2021-00223
    Event Type
    Death
    Date Received
    March 19, 2021
    Report Date
    December 12, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ZISV6 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. 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 ZISV6 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT DEATH IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE (IFU0118-6). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/UNDERLYING CONDITIONS. THE PAPER SPECIFIES THAT THEY DID NOT FOLLOW UP ON THE CAUSES OF DEATHS. FROM THE LITERATURE ARTICLE IT IS KNOWN THAT PATIENT PRE-EXISTING CONDITIONS INCLUDED HYPERTENSION, HYPERLIPIDEMIA, DIABETES, SMOKING, CORONARY ARTERY DISEASE (CAD), RENAL INSUFFICIENCY, OBESITY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CEREBROVASCULAR DISEASE, INTERMITTENT CLAUDICATION, AND ISCHEMIC HEART DISEASE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALL 12 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) #: P100022/S027. (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 PTX, 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 12 PATIENTS (12.0% OF 101 PATIENTS IN PES GROUP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420931 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death