BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 15864368 · Received November 25, 2022

    Report

    Report Number
    3001845648-2022-00802
    Event Type
    Injury
    Date Received
    November 25, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 27, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMMON NAME: QAN PMA/510(K) # P200023 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. THIS FILE IS RELATED TO (B)(6) LAB EVALUATION ¿ N/A DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO 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 COULD NOT BE DETERMINED HOWEVER A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS. THE IFU LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM THE CLINICAL STUDY ¿EVALUATION OF THE ZILVER VENA VENOUS STENT IN SPAIN ¿ DR. MARTA RAMIREZ ORTEGA (PHYSICIAN ¿ DRIVEN STUDY ¿ AMBISPECTIVE REVIEW OF PATIENTS UNDERGOING PROXIMAL VENOUS STENT PLACEMENT). ACCORDING TO THE LITERATURE PAPER, 07 PATIENTS EXPERIENCED RESTENOSIS. THIS COMPLAINT CAPTURES 01 CASE OF RESTENOSIS REQUITING A CT SCAN, NO FURTHER INTERVENTIONS WERE REPORTED FOR THIS PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE MAIN OBJECTIVE OF THIS AMBISPECTIVE, SINGLE CENTER, NONRANDOMIZED, SINGLE-ARM, PHYSICIAN-DRIVEN STUDY WAS TO EVALUATE THE PATENCY OF THE ZILVER® VENA¿ VENOUS SELF-EXPANDING STENT (I.E., THE ZILVER® VENA¿ VENOUS STENT) IN PATIENTS UNDERGOING VENOUS STENTING. THIS REPORT FOCUSES ON DATA FROM THE 239 PATIENTS THAT HAD A ZILVER VENA VENOUS STENT PLACED AT AN INDEX PROCEDURE. (B)(6) HAD RESTENOSIS AND REQUIRED IMAGING. TIME TO DIAGNOSIS 608 DAYS. RELATED TO DEVICE; NOT RELATED TO PROCEDURE. IMAGING MODALITY TO DIAGNOSE EVENT CT. PATIENT OUTCOME: PATIENT REQUIRED IMAGING.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 27JAN2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686835 ZILVER VENA VENOUS SELF EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention