BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 17413301 · Received July 28, 2023

    Report

    Report Number
    3001845648-2023-00587
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    May 28, 2022
    Report Date
    January 31, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P200023. DEVICE EVALUATION THE ZILVER VENA VENOUS SELF EXPANDING STENT DEVICE OF RPN AND LOT NUMBER UNKNOWN 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. THIS COMPLAINT WAS RAISED FROM LITERATURE PAPER HÜGEL 2023 AND CAPTURES THE USER ERROR OF THE INCORRECT SIZE ACCESS SHEATH USED AND THE POSSIBILITY OF THE INCORRECT SIZE WIRE GUIDE (0.018") IN IRAN. IT IS RELATED TO THE FOLLOWING FILES- (B)(4) - HÜGEL 2023 - ¿STENT OCCLUSION¿ (SWITZERLAND), (B)(4) - HÜGEL 2023 - ¿STENT OCCLUSION¿ (IRAN), (B)(4) - HÜGEL 2023 - ¿STENT FRACTURE¿ (SWITZERLAND), (B)(4) - HÜGEL 2023 - ¿STENT FRACTURE¿ (IRAN), (B)(4) - USER ERROR (SWITZERLAND). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU/LABEL REVIEW: IT SHOULD BE NOTED THAT INSTRUCTIONS FOR USE (IFU0047), STATES THE FOLLOWING: ¿GAIN ACCESS AT THE APPROPRIATE SITE UTILIZING A 2.3MM (7.0 FRENCH) INTRODUCER SHEATH¿. IT ALSO STATES "INTRODUCE AN .035 INCH (0.89MM) WIRE GUIDE THROUGH THE INTRODUCER SHEATH OR GUIDING CATHETER". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE INSTRUCTIONS FOR USE HAS BEEN DETERMINED. FROM THE ADDITIONAL QUESTIONS IT IS KNOWN THAT AN 10FR ACCESS SHEATH WAS USED WITH THE DEVICE. AS PREVIOUSLY NOTED, THE IFU STATES ¿GAIN ACCESS AT THE APPROPRIATE SITE UTILIZING A 2.3MM (7.0 FRENCH) INTRODUCER SHEATH¿. IT WAS ALSO STATED THAT THE CROSSING OF VENOUS LESIONS WAS ATTEMPTED WITH EITHER A 0.035-INCH WIRE GUIDE OR WITH A 0.018-INCH WIRE GUIDE. AS PREVIOUSLY NOTED THE IFU INSTRUCTS THE USE OF A 0.035 INCH WIRE GUIDE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY . SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS COMPLAINT AROSE FROM LITERATURE PAPER HÜGEL 2023 ZILVER VENA, ¿CRITERIA TO PREDICT MIDTERM OUTCOME AFTER STENTING OF CHRONIC ILIAC VEIN OBSTRUCTIONS (PROMISE TRIAL).¿ THEY RETROSPECTIVELY ANALYZED A SERIES OF PROSPECTIVELY ENROLLED, CONSECUTIVE PATIENTS WHO UNDERWENT VENOUS STENT PLACEMENT FOR CHRONIC VEIN OBSTRUCTIONS DUE TO PTO OR NIVLS AT THE DIVISION OF ANGIOLOGY, UNIVERSITY HOSPITAL OF BERN, SWITZERLAND, BETWEEN JANUARY 1, 2008, AND JULY 1, 2020. THIS COMPLAINT WAS OPENED TO CAPTURE THE USER ERROR OF THE INCORRECT SIZE ACCESS SHEATH USED AND THE POSSIBILITY OF THE INCORRECT SIZE WIRE GUIDE (0.018") IN IRAN. CONFIRMED QUANTITY OF 14 DEVICES, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO ADVERSE EFFECTS REPORTED AS OCCURRING TO THE PATIENT. THE USER ERRORS WOULD NOT HAVE CONTRIBUTED TO ANY COMPLICATIONS AS THE TECHNICAL SUCCESS OF THE PROCEDURES WAS 100%. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE INSTRUCTIONS FOR USE HAS BEEN DETERMINED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    HÜGEL 2023, ZILVER VENA, ¿CRITERIA TO PREDICT MIDTERM OUTCOME AFTER STENTING OF CHRONIC ILIAC VEIN OBSTRUCTIONS (PROMISE TRIAL).¿ WE RETROSPECTIVELY ANALYZED A SERIES OF PROSPECTIVELY ENROLLED, CONSECUTIVE PATIENTS WHO UNDERWENT VENOUS STENT PLACEMENT FOR CHRONIC VEIN OBSTRUCTIONS DUE TO PTO OR NIVLS AT THE DIVISION OF ANGIOLOGY, UNIVERSITY HOSPITAL OF BERN, SWITZERLAND, BETWEEN JANUARY 1, 2008, AND JULY 1, 2020. STENTING PROCEDURE: IN PATIENTS WITH NIVLS, ENDOVENOUS STENT IMPLANTATION WAS UNDERTAKEN USING INTRAVENOUS REMIFENTANIL FOR ANALGESIA AND PROPOFOL FOR LIGHT SEDATION. IN VIEW OF HIGHER PAIN LEVELS, ASSOCIATED WITH DILATATION OF POST-THROMBOTIC CHANGES, STENTING FOR PTO WAS TREATED UNDER GENERAL ANESTHESIA. AFTER ULTRASOUNDGUIDED ACCESS HAD BEEN ESTABLISHED VIA POPLITEAL OR FEMORAL VEINS USING 10F SHEATHS, BIPLANE VENOGRAMS WERE OBTAINED BY DIGITAL SUBTRACTION ANGIOGRAPHY WITH A FRAME RATE OF TWO IMAGES PER SECOND. SUBSEQUENTLY, CROSSING OF VENOUS LESIONS WAS ATTEMPTED WITH STIFF, ANGLED 0.035-INCH HYDROPHILIC WIRES (TERUMO CORPORATION) OR WITH 0.018-INCH WIRES (ASTATO 30; ASAHI-INTECC). THE FOLLOWING STENTS WERE USED DEPENDING ON THE TARGET LESION LOCATION: (1) IN THE COMMON ILIAC VEIN, SINUS XL STENT (OPTIMED), VENOVO VENOUS STENT (BARD MEDICAL), SINUS OBLIQUUS STENT (OPTIMED), AND VICI VENOUS STENT (BOSTON SCIENTIFIC); (2) IN THE EXTERNAL ILIAC VEIN OR CFV, SINUS XL FLEX STENT (OPTIMED) OR ZILVER VENA STENT (COOK); AND (3) FOR EXTENSION INTO THE DFV OR FV, SINUS SUPERFLEX STENT (OPTIMED). POSTDILATATION WAS PER-FORMED TO ACHIEVE COMPLETE STENT EXPANSION AND SATIS-FACTORY ALIGNMENT. SUBSEQUENTLY, A VENOGRAM WAS OBTAINED TO CONFIRM STENT PATENCY, ADEQUATE ADAPTION TO THE VESSEL WALL, AND COVERAGE OF THE ENTIRE LESION. PATIENTS RECEIVED 5000 IU OF UNFRACTIONATED HEPARIN INTRA-PROCEDURALLY WITH REPEATED ADMINISTRATION EVERY 2 HOURS. ALL PROCEDURES WERE PERFORMED BY INTERVENTIONALISTS WITH SEVERAL YEARS OF EXPERIENCE. WE ENSURED COMPLETE COVERAGE OF POST-THROMBOTIC VENOUS SEGMENTS IN THE ILIOFEMORAL VEINS, WHILE AVOIDING JAILING OF THE CONTRALATERAL SIDE BY USING THE SINUS OBLIQUUS STENT (OPTIMED) IN COMMON ILIAC VEINS. ANTICOAGULATION WAS INITIATED AFTER COMPLETION OF THE PROCEDURE USING FULL-DOSE LOW-MO-LECULAR-WEIGHT HEPARIN FOR 24 HOURS, FOLLOWED BY VITAMIN K ANTAGONISTS OR DIRECT ORAL ANTICOAGULANTS. THE CHOICE OF SPECIFIC ANTICOAGULANT WAS AT THE DISCRETION OF THE INTER-VENTIONALIST. ORAL ANTICOAGULATION WAS CONTINUED FOR A MINIMUM OF 6 MONTHS IN PATIENTS WITH NIVLS AND FOR AT LEAST 12 MONTHS OR INDEFINITELY IN PATIENTS WITH POST-THROMBOTIC LESIONS. COMPRESSION THERAPY IN USE WAS CONTINUED AFTER THE INTERVENTION. REQUIREMENT FOR LONG-TERM COMPRESSION THERAPY WAS DETERMINED DURING FOLLOW-UP VISITS. THIS COMPLAINT WAS OPENED TO CAPTURE THE USER ERROR OF THE INCORRECT SIZE ACCESS SHEATH USED IN IRAN. (B)(6) - ¿STENT OCCLUSION¿ (SWITZERLAND), (B)(6) - ¿STENT OCCLUSION¿ (IRAN), (B)(6) - ¿STENT FRACTURE¿ (SWITZERLAND), (B)(6) - ¿STENT FRACTURE¿ (IRAN). NO ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 31-JAN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320709 ZILVER VENA VENOUS SELF EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male