BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 18940782 · Received March 20, 2024

    Report

    Report Number
    3001845648-2024-00103
    Event Type
    Injury
    Date Received
    March 20, 2024
    Report Date
    August 1, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P200023. DEVICE EVALUATION: THE ZILVER VENA OF UNKNOWN LOT NUMBER AND RPN, INVOLVED IN THIS COMPLAINT, WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICES OR PHOTOGRAPHIC EVIDENCE OF THE DEVICES WERE NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: IT SHOULD BE NOTED THAT THROMBOSIS OF THE STENTED VEIN IS LISTED AS A POTENTIAL ADVERSE EVENT OF THIS DEVICE IN THE IFU (IFU0091). THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS CAUSED OR CONTRIBUTED TO THE EVENT OF THROMBOSIS. FROM THE INFORMATION AVAILABLE, IT IS KNOWN THAT THE DEVICE WAS PLACED BECAUSE OF A DEEP VEIN THROMBOSIS AND CHRONIC OBSTRUCTION. PATIENT OUTCOME WAS SUCCESSFUL INITIALLY FOLLOWING ZILVER VENA STENT PLACEMENT IN THE ILIAC VEIN BUT THEN THE PATIENT SUBSEQUENTLY DEVELOPED ANOTHER DVT. THAT IS WHEN THE DOCTOR HAD TO USE INARI¿S REVCORE DEVICE TO SCRAPE CLOT OUT OF THE PREVIOUS PLACED STENT. THIS DEVICE PULLED THE ZILVER VENA STENT OUT ENTIRELY. AS PER INFORMATION PROVIDED IN THE DESCRIPTION OF EVENT, THE DOCTOR DOES NOT FAULT OUR ZILVER VENA STENT, ONLY THE REV CORE DEVICE. THE USER WISHED TO REPORT THE ISSUE AS A CAUTIONARY MESSAGE FOR USERS OF THE REV CORE DEVICE. THE STENT REMOVAL WAS NOT DUE TO AN ISSUE WITH THE COOK DEVICE. THE INSTRUCTIONS FOR USE FOR THE COOK DEVICE LISTS THROMBOSIS AS A POTENTIAL ADVERSE EVENT. COOK DO NOT INSTRUCT USERS HOW TO TREAT THROMBOSIS. AS PREVIOUSLY MENTIONED, THROMBOSIS OF THE STENTED VEIN IS LISTED AS A POTENTIAL ADVERSE EVENT OF THIS DEVICE IN THE IFU (IFU0091). CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, THE DOCTOR HAD PREVIOUSLY PLACED A ZILVER VENA IN THE PATIENT¿S ILIAC VEIN. THE STENT HAD SHUT DOWN AND RETHROMBOSED SO HE PULLED REV CORE TO TRY AND OPEN THE STENT AGAIN. AFTER DOING A FEW PASSES THEY REALIZED THE DEVICE HAD PULLED OUT THE STENT ENTIRELY. THE DOCTOR DOES NOT FAULT OUR STENT, ONLY THE REV CORE DEVICE. CONFIRMED QUANTITY OF 01 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THERE WAS (B)(4) OCCURRENCE OF DEEP VEIN THROMBOSIS WHICH PER MEDICAL ADVISOR INPUT WOULD REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO TREAT RETHROMBOSIS S=+4. INVESTIGATION FINDINGS CONCLUDE POSSIBLE ROOT CAUSES COULD BE ATTRIBUTED TO THE PATIENTS PRE-EXISTING CONDITIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL SIMILAR EVENTS.

    Description of Event or Problem · 0

    PER REP - 21FEB2024- I WAS SPEAKING WITH A PHYSICIAN ABOUT A PREVIOUS CASE HE HAD IN WHICH HE USED INARI¿S REV CORE DEVICE. THIS DEVICE IS INDICATED FOR CLEARING OUT ISR FROM VENOUS STENTS. THE DOCTOR HAD PREVIOUSLY PLACED A ZILVER VENA IN THE PATIENT¿S ILIAC VEIN. THE STENT HAD SHUT DOWN AND RETHROMBOSED SO HE PULLED REV CORE TO TRY AND OPEN THE STENT AGAIN. AFTER DOING A FEW PASSES THEY REALIZED THE DEVICE HAD PULLED OUT THE STENT ENTIRELY. THE DOCTOR DOES NOT FAULT OUR STENT, ONLY THE REV CORE DEVICE. I WANTED TO REPORT THIS AS A CAUTIONARY MESSAGE FOR REV CORE USERS. THE STENT PLACEMENT WAS SO LONG AGO HE DOES NOT KNOW WHICH ZILVER VENA IT WAS. I ASKED FOR IMAGES FROM THE CASE AND HOPE TO HEAR BACK FROM HIM.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048275 ZILVER VENA VENOUS SELF-EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention