BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 15112993 · Received July 27, 2022

    Report

    Report Number
    3001845648-2022-00474
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Report Date
    September 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL 510K + PRODUCT CODES: ZIV P050017/S002 AND S003 NIO, ZILVER FLEX P050017/S006 NIO, ZILVER VENA P200023 QAN. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    POTENTIAL 510K + PRODUCT CODES: ZIV P050017/S002 AND S003 NIO ZILVER FLEX P050017/S006 NIO ZILVER VENA P200023 QAN DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT IS NOT KNOWN FROM THE JOURNAL ARTICLE WHAT DEVICE WAS USED IN THE STUDY SO THE INVESTIGATION IS BASED ON A ZIV DEVICE AS PER MEDICAL ADVISOR INPUT, REFER ATTACHMENTS. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZIV DEVICES ARE SUBJECTED TO A VISUAL AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0043-9) STATES THE FOLLOWING: ¿THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. THE INFORMATION FOR USE STATES THAT THE DEVICE IS INTENDED FOR USE IN THE ILIAC ARTERIES HOWEVER, FROM THE INFORMATION PROVIDED THE TARGET LOCATION WAS THE LEFT SUBCLAVIAN ARTERY. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    BI ET AL 2022 (ZILVER) - MIDTERM OUTCOMES OF FENESTRATED TEVAR USING PHYSICIAN-MODIFIED ENDOVASCULAR GRAFTS FOR ZONE 2. THE BRIDGING STENTS WAS DEPLOYED ALONG THE SUPRACORE GUIDEWIRE THAT REPLACED THE PRE-LOADED GUIDEWIRE, AND THE PROXIMAL USUALLY ENTERS INTO THE PMEGS LUMEN FOR ABOUT 1 CM. THE DISTAL SHOULD NOT EXCEED THE ORIGIN OF THE LEFT VER-TEBRAL ARTERY. THE BRIDGING STENTS INCLUDED COVERED STENTS [FLUENCY (BD/BARD PERIPHERAL VASCULAR, TEMPE, AZ, USA) OR VIABAHN (GORE MEDICAL, FLAGSTAFF, AZ, USA)] AND BARE STENTS [S.M.A.R.T.(CORDIS CORPORATION, A CARDINAL HEALTH COMPANY, (B)(6) USA), ZILVER (COOK MEDICAL) N=2, OR PROTEGE GPS (EV3, PLYMOUTH, MN, USA)]. OFF-LABEL: USE IN LEFT SUBCLAVIAN ARTERY NO ADVERSE EFFECTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944610 ZILVER 635 VASCULAR SELF-EXPANDING STENT STENT, ILIAC NIO COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male