BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 15334651 · Received September 1, 2022

    Report

    Report Number
    3001845648-2022-00599
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Report Date
    January 20, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023. PRODUCT CODE: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023. PRODUCT CODE: QAN. ONE ZVT7-35-120-16-60 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZVT7-35-120-16-60 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IFU0091 STATE ¿INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED¿. THERE IS NO 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 COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO IMPACT OR EXCESSIVE PRESSURE THAT MAY HAVE BEEN PLACED ON THE PACKAGED DEVICE DURING TRANSPORTATION OR STORAGE. IT IS POSSIBLE THAT THIS PRESSURE OR IMPACT MAY HAVE CAUSED THE STENT TO PARTIALLY DEPLOY. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DAMAGE WAS NOTED BEFORE PATIENT CONTACT. THE DEVICE WAS NOT USED FOR THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    UPON OPENING PRODUCT PACKAGE, STENT WAS ¿PARTIALLY DEPLOYED¿ OUT OF PACKAGE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND THEY ARE NOT UPSET.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20JAN2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831407 ZILVER VENA VENOUS SELF-EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown