BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 15102231 · Received July 26, 2022

    Report

    Report Number
    3001845648-2022-00462
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    May 31, 2022
    Report Date
    October 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P050017/S006 DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER FLEX (ZFV6) DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058-4) STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY FOR THE FOLLOWING TREATMENTS: ARTERIOSCLEROTIC STENOSIS, TOTAL OCCLUSIONS THAT HAVE BEEN RECANALIZED.¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. 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, SFA AND ABOVE-THE-KNEE POPLITEAL ARTERY HOWEVER, FROM THE INFORMATION PROVIDED, THE TARGET LOCATION WAS THE DURAL SINUS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER YEN-HENG LIN ET AL 2021 ¿CLINICAL OUTCOMES OF ADJUNCT SINUS STENTING IN DURAL ARTERIOVENOUS FISTULAS¿. ACCORDING TO THE INITIAL REPORTER, NO DEVICE RELATED ADVERSE EVENTS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    YEN-HENG LIN ET AL 2021 (ZILVER FLEX) ¿ ¿CLINICAL OUTCOMES OF ADJUNCT SINUS STENTING IN DURAL ARTERIOVENOUS FISTULAS¿. ANGIOPLASTY WAS PERFORMED FIRST WITH A MONORAIL ANGIOPLASTY BALLOON AFTER SUCCESSFUL WIRE CROSSING OF THE INVOLVED DURAL SINUS TO PERFORM SINUS STENTING. FOR AN OCCLUDED SINUS, A 0.035-INCH GUIDEWIRE OR 0.027-INCH MICROCATHETER-MICROWIRE KIT (PROGREAT, TERUMO, TOKYO, JAPAN) WAS USED ALONG WITH DIAGNOSTIC OR GUIDING CATHETERS APPLIED IN A COAXIAL OR TRIAXIAL MANNER. AFTER ANGIOPLASTY, STENTS OF VARIABLE SIZES AND LENGTHS WERE USED; SUCH STENTS WERE PRIMARILY SELF-EXPANDABLE NITINOL STENTS (PRECISE, CORDIS, SANTA CLARA, CA, USA AND ZILVER FLEX, COOK MEDICAL, BLOOMINGTON, IN, USA) AND OCCASION-ALLY BALLOON-EXPANDABLE STENT GRAFTS (GRAFTMASTER, ABBOTT, CHICAGO, IL, USA). MOREOVER, A GUIDING SHEATH WAS PLACED INTO THE SINUS IF FEASIBLE TO FACILITATE STENT PLACEMENT. IN ADDITION TO STENT PLACEMENT, ENDOVASCULAR EMBOLIZATION WAS PERFORMED EITHER BEFORE OR AFTER STENT PLACEMENT. THE GOAL WAS TO SUFFICIENTLY REDUCE THE FLOW OF AVF. NOTABLY, THE EMBOLIZATION PROCESS WAS PERFORMED THROUGH EITHER A TRANSARTERIAL OR A TRANSVENOUS ROUTE USING VARIOUS EM-BOLIC MATERIALS, INCLUDING COILS, N-BUTYL-2-CYANOACRYLATE (HISTOACRYL®, B. BRAUN, MELSUNGEN, GERMANY), AND ETHY-LENE-VINYL ALCOHOL (ONYX¿, MEDTRONIC, DUBLIN, IRELAND). BALLOON-ASSISTED TECHNIQUES WERE NOT USED DURING ONYX INJECTION. THE PROCEDURES WERE OCCASIONALLY PERFORMED IN STAGES, WITH THE STENTING AND EMBOLIZATION PERFORMED AT DIFFERENT SESSIONS. OFF LABEL USE: ZILVER FLEX USED IN DURAL SINUS. NO DEVICE RELATED ADVERSE EFFECTS REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724206 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female