BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 12795851 · Received November 11, 2021

    Report

    Report Number
    3001845648-2021-00801
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 13, 2021
    Report Date
    January 28, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME - QAN. PMA # - P200023. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    COMMON NAME - QAN, PMA # - 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. DEVICE EVALUATION: THE ZVT7-35-80-16-140 DEVICE OF LOT NUMBER C1849096 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZVT7-35-80-16-140 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL . A REVIEW OF THE MANUFACTURING RECORDS FOR ZVT7-35-80-16-140 OF LOT NUMBER C1849096 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 C1849096. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IFU0091-7 STATES THE FOLLOWING: ¿THE CHOSEN STENT DIAMETER SHOULD BE OVERSIZED 1-4MM WITH RESPECT TO THE ESTIMATED VESSEL DIAMETER AS DETERMINED BY THE BEST AVAILABLE ASSESSMENT¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER IMPRESSION: THE COMPLAINT OF EXCESSIVE STENT SHORTENING IS NOT CONFIRMED. THE STENT DID LAND 12MM SHORT OF ITS INTENDED TARGET. THIS WAS BECAUSE THE TARGET WAS SET ON THE NEARLY STRAIGHT COURSE OF THE UNDEPLOYED STENT RATHER THAN THE IMPLANTATION VEIN¿S CURVED PATH. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. AS PER THE INSTRUCTIONS FOR USE IFU0091-7, ¿THE CHOSEN STENT DIAMETER SHOULD BE OVERSIZED 1-4MM WITH RESPECT TO THE ESTIMATED VESSEL DIAMETER AS DETERMINED BY THE BEST AVAILABLE ASSESSMENT¿. THE IMAGE REVIEW CONFIRMED THAT THE SELECTED STENT WAS SHORTER THAN REQUIRED FOR THE LESION THAT WAS BEING TREATED. THE CUSTOMER¿S TESTIMONY COULD NOT BE CONFIRMED, HOWEVER THE COMPLAINT IS CONFIRMED BASED ON THE FAILURE VERIFIED IN THE INVESTIGATION. THE COMPLAINT OF STENT SHORTENING COULD NOT BE CONFIRMED AS THE DEFECT COULD NOT BE VERIFIED IN THE IMAGES. HOWEVER, USER ERROR WAS CONFIRMED IN THE IMAGES. 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

    A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT A PLACEMENT OF VENA STENT THROUGH RIGHT FEMORAL VEIN APPROACH IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449, WAS USED. CAUDAL PORTION OF STENT FORESHORTENED UPON DEPLOYMENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO IMAGINING REVIEW COMPLETED ON 23-NOV-2021 WHICH INDICATES USER ERROR: IMAGING REVIEW COMPLETED ON 23-NOV-21: IMPRESSION: THE COMPLAINT OF EXCESSIVE STENT SHORTENING IS NOT CONFIRMED. THE STENT DID LAND 12MM SHORT OF ITS INTENDED TARGET. THIS WAS BECAUSE THE TARGET WAS SET ON THE NEARLY STRAIGHT COURSE OF THE UNDEPLOYED STENT RATHER THAN THE IMPLANTATION VEIN¿S CURVED PATH.

    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
    1699610 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57449 C1849096 10827002574493

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown