BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VASCULAR SELF-EXPANDING STENT

    MDR report key: 9590243 · Received January 15, 2020

    Report

    Report Number
    3001845648-2020-00036
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    January 9, 2018
    Report Date
    September 17, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003 THE ZILVER VASCULAR SELF-EXPANDING STENT DEVICE OF LOT NUMBER UNKNOWN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. PRIOR TO DISTRIBUTION ZILVER VASCULAR SELF-EXPANDING STENT DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ¿THIS PRODUCT IS INTENDED FOR USE IN THE ILIAC ARTERIES¿ A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE COVERED STENTS WERE ROUTINELY LINED WITH SUPPORTING UNCOVERED STENTS, USING EITHER A WALLSTENT (BOSTON SCIENTIFIC, NATICK, MASS) OR A ZILVER STENT (COOK MEDICAL).THE STENTS WERE USED IN THE RENAL AND VISCERAL BRANCHES. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO CLINICAL INPUT ALL COMPLICATIONS SEEMS TO BE RELATED TO ZENITH STENT GRAFT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 10JAN2020--DID 10JAN2020. AS REPORTED TO CUSTOMER RELATIONS: "WALKER ET AL 2019 ¿ ¿LONG-TERM DURABILITY OF MULTIBRANCHED ENDOVASCULAR REPAIR OF THORACOABDOMINAL AND PARARENAL AORTIC ANEURYSMS¿. OFF LABEL USE: THE COVERED STENTS WERE ROUTINELY LINED WITH SUPPORTING UNCOVERED STENTS, USING EITHER A WALLSTENT (BOSTON SCIENTIFIC, NATICK, MASS) OR A ZILVER STENT (COOK MEDICAL). THE UNCOVERED STENTS WERE ALSO USED IN THE RENAL AND VISCERAL BRANCHES, ALSO OFF LABEL USE."

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 10JAN2020--DID 10JAN2020. AS REPORTED TO CUSTOMER RELATIONS: "WALKER ET AL 2019  LONG-TERM DURABILITY OF MULTIBRANCHED ENDOVASCULAR REPAIR OF THORACOABDOMINAL AND PARARENAL AORTIC ANEURYSMS. OFF LABEL USE: THE COVERED STENTS WERE ROUTINELY LINED WITH SUPPORTING UNCOVERED STENTS, USING EITHER A WALLSTENT (BOSTON SCIENTIFIC (B)(4)) OR A ZILVER STENT (COOK MEDICAL). THE UNCOVERED STENTS WERE ALSO USED IN THE RENAL AND VISCERAL BRANCHES, ALSO OFF LABEL USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56598 ZILVER VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1