BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 12084457 · Received June 29, 2021

    Report

    Report Number
    3001845648-2021-00526
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    February 12, 2020
    Report Date
    February 11, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. DEVICE EVALUATION: THE UNKNOWN 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. 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 ALL ZILVER FLEX 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 IFU. (IFU0058-4) A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO PATIENTS PRE-EXISTING MEDICAL CONDITIONS, SUCH AS OBESITY. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS REQUIRED SURGICAL INTERVENTION. 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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    SPYCHALSKA-ZWOLINSKA, 2020, ZILVER FLEX, NUTRITIONAL STATUS AND OUTCOMES OF SUPERFICIAL FEMORAL ARTERY STENTING DUE TO INTERMITTENT CLAUDICATION. PATIENTS UNDERGOING FEMORAL ARTERY STENTING WERE ACCEPTED FOR THE PROCEDURE FOLLOWING ASSESSMENT BY AN ANGIOLOGIST AND ENROLLED TO THE STUDY ONLY WHEN TECHNICAL SUCCESS, DEFINED AS OBTAINING SFA PATENCY WITH RAPID OUTFLOW AND RESIDUAL ANGIOGRAPHIC STENT STENOSIS OF <20%,13 WAS ACHIEVED. NONE OF THE PATIENTS FROM THE STUDY GROUP HAD PREVIOUSLY BEEN TREATED INVASIVELY (EITHER SURGICALLY OR ENDOVASCULARLY) BUT NOW QUALIFIED FOR SFA STENTING WITH A SELF-EXPANDABLE (UNCOATED) PLANE STENT (ZILVER FLEX, COOK MEDICAL, BLOOMINGTON, IN, USA) DUE TO A LIFE-LIMITING SHORTENING IN WALKING DISTANCE. DURING THE FOLLOW-UP PERIOD IN OUR STUDY (583.23±273.60 DAYS), 21 (30.0%) PATIENTS NEEDED TLR TLR WAS DEFINED AS A RE-INTERVENTION PERFORMED FOR >50% DIAMETER STENOSIS WITHIN 5 MM OF THE TARGET LESION AFTER THE DOCUMENTATION OF RECURRENT CLINICAL SYMPTOMS OF LEG ISCHEMIA, AND FURTHER EVIDENCED BY A DECREASE IN ABI IN COMPARISON TO VALUES OBTAINED AFTER THE FIRST ENDOVASCULAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978731 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