BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 14235491 · Received April 28, 2022

    Report

    Report Number
    3001845648-2022-00258
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 31, 2022
    Report Date
    September 9, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002520278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT CODE - QAN PMA/510(K) # (B)(6) DEVICE EVALUATION THE ZVT7-35-80-16-6.0 DEVICE OF LOT NUMBER C1746098 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6)20TH JUNE 2022. ON EVALUATION OF THE DEVICE IT WAS OBSERVED ON VISUAL INSPECTION THAT THE RED SAFETY TAB WAS NOT RETURNED, THE STENT WAS NOT RETURNED AND A 0.035'' WIRE GUIDE WAS RETURNED INSERTED IN DELIVERY SYSTEM. UPON FUNCTIONAL INSPECTION, THE 0.035'' WIRE GUIDE WAS UNABLE TO BE REMOVED FROM THE DELIVERY SYSTEM. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZVT7 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZVT7-35-80-16-6.0 OF LOT NUMBER C1746098 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1746098. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047-5) STATES THE FOLLOWING: ¿THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU AS IN THE COMPLAINT REPORTING FORM THE PHYSICIAN HAS TOLD HOW HE USED THE STENT TO PERFORM SVC (SUPERIOR VENA CAVA) STENTING. THIS IS REGARDED AS OFF LABEL USE. ROOT CAUSE A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE INFORMATION SUPPLIED. SUMMARY COMPLAINT IS CONFIRMED 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

    THE TIP OF THE DELIVERY SHEATH OF THE STENT IS STUCKED WITH AMPLATZ .035" WIRE GUIDE. IT CANNOT BE WITHDRAWN THROUGH THE WIRE, PHYSICIAN NEED TO PULL OUT THE WHOLE SYSTEM TOGETHER FROM PATIENT JUGULAR ACCESS. USED WITH TERUMO GLIDE WIRE .035" X150CM AND CORDIS COBRA CATHETER 5FR X 65CM BEFORE INTRODUCING THE STENT [UPDATE FROM SALES REPRESENTATIVE] THE STENT WAS DONE DEPLOYED IN PATIENT. DOCTOR COULD ONLY PULL OUT THE WHOLE DELIVERY SHEATH AND WIRE GUIDE ALTOGETHER AS MENTIONED IN THE FORM, AND PUT IN TERUMO WIRE GUIDE TO THE TRACT. DID ANY PIECE OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE COMPLAINANT INFORM OF ANY ADVERSE EFFECT(S) ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE COMPLAINANT INFORM THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECT(S)? NO.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BRING SUBMITTED DUE TO COMPLETION OF LAB EVALUATION ON 20TH JUNE 2022: LAB EVALUATION 20TH JUNE : VISUAL INSPECTION RED SAFETY TAB NOT RETURNED STENT NOT RETURNED. 0.035'' WIRE GUIDE RETURNED INSERTED IN DELIVERY SYSTEM FUNCTIONAL INSPECTION UNABLE TO REMOVE 0.035'' WIRE GUIDE FROM DELIVERY SYSTEM

    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
    265674 ZILVER VENA VENOUS SELF-EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD C1746098 10827002520278

    Patients

    Seq Age Sex Outcome Treatment
    1 Female