BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 10248359 · Received July 8, 2020

    Report

    Report Number
    3001845648-2020-00414
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    October 20, 2013
    Report Date
    January 14, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT 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 ZFV6 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 STENT STRUT FRACTURE IS LISTED AS A KNOWN POTENTIAL ADVERSE EVENT WITHIN THE INSTRUCTIONS FOR USE IFU0058-4. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY AND/OR STENT FATIGUE. DIFFICULT PATIENT ANATOMY AND/OR LOCATION OF THE STENT IN THE BODY MAY HAVE PLACED EXCESSIVE FORCE ON THE STENT CONTRIBUTING TO STENT FATIGUE RESULTING IN STENT FRACTURE. IT IS POSSIBLE THAT THE STENT COURSED UNDER A LIGAMENT IN THE ANATOMY OR WAS PLACED AT A JOINT (E.G. KNEE JOINT OR HIP JOINT) CONTRIBUTING TO STRESS AND FATIGUE FROM JOINT FLEXION/MOVEMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT OUTCOME IS UNKNOWN HOWEVER, CLINICAL INPUT SUGGESTS THAT THE STENT FRACTURES WOULD LIKELY HAVE REQUIRED A FORM OF 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

    TIEN-YU WU ET AL 2013-"COMPARISON OF IMMEDIATE AND 2-YEAR OUTCOMES BETWEEN EXCIMER LASER-ASSISTED ANGIOPLASTY WITH SPOT STENT AND PRIMARY STENTING IN INTERMEDIATE TO LONG FEMOROPOPLITEAL DISEASE". SELF-EXPANDING NITINOL STENTS WERE IMPLANTED IN GROUP B EITHER BY DIRECT STENTING OR WITH PREDILATATION OF UNDERSIZED BALLOON. ONE CENTIMETER OF OVERLAP WAS EMPLOYED WHEN MULTIPLE STENTS WERE REQUIRED TO COVER THE TREATED ARTERIAL SEGMENTS. VARIOUS TYPES OF SELF-EXPANDING NITINOL STENTS INCLUDING ZILVER AND ZILVER FLEX (25) WERE USED DURING THE EVI AT THE DISCRETION OF THE OPERATORS. THE RATES OF STENT FRACTURE WERE ALSO NOT DIFFERENT BETWEEN THE 2 GROUPS EITHER AT 12 OR 24MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710882 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention