BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 15864358 · Received November 25, 2022

    Report

    Report Number
    3001845648-2022-00804
    Event Type
    Injury
    Date Received
    November 25, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 17, 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: (B)(6). 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 PR (B)(4). 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 THE PROCEDURE. ACCORDING TO THE LITERATURE PAPER, THE EVENT WAS ¿NOT RELATED TO ZILVER VENA, IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS OR THROMBOSIS (OCCLUSION) 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. (B)(6) (PHYSICIAN ¿ DRIVEN STUDY ¿ AMBISPECTIVE REVIEW OF PATIENTS UNDERGOING PROXIMAL VENOUS STENT PLACEMENT). ACCORDING TO THE LITERATURE PAPER, 01 PATIENT EXPERIENCED STENT OCCLUSION SYMPTOMS WHICH RESULTED IN AN ENDOVASCULAR TREATMENT AND ADDITIONAL STENT PLACEMENT 22 DAYS POST-PROCEDURE. AS PER MEDICAL ADVISOR INPUT ¿REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE¿. 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. PATIENT 18 HAD RESTENOSIS/RECURRENCE OF SYMPTOMS AND REQUIRED STENT REPLACEMENT. PATIENT 18 HAD A STENT OCCLUSION, WHICH RESULTED IN AN ENDOVASCULAR TREATMENT AND ADDITIONAL STENT PLACEMENT 22 DAYS POST-PROCEDURE AS REPORTED IN TABLE 3.9.1-2. 26 DAYS POST-PROCEDURE NEW THROMBOSIS WAS NOTED PARTIALLY IN THE ILIAC SEGMENT AND ALL OF THE FEMORAL VEIN STENT. THIS WAS REPORTED ALL AS ONE EVENT BY THE PHYSICIAN. RESTENOSIS/RECURRENCE OF THROMBSIS SYMPTOMS: TIME TO DIAGNOSIS 26 DAYS. RELATED TO THE PROCEDURE; RESIDUAL THROMBOSIS AFTER LYSIS OF INFLOW. IMAGING MODALITY TO DIAGNOSE EVENT ULTRSOUND. NO NEW INTERVENTION HAS BEEN PERFORMED TO TREAT THE THROMBUS NOTED 26 DAYS POST-PROCEDURE. PATIENT OUTCOME: REQUIRED IMAGING, ENDOVASCULAR TREATMENT AND STENT REPLACEMENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-JAN-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686825 ZILVER VENA VENOUS SELF EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention