BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 20794865 · Received November 27, 2024

    Report

    Report Number
    3001845648-2024-00698
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Report Date
    June 5, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    PMA / PMN Number
    P200023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    DEVICE EVALUATION: THE ZILVER VENA VENOUS SELF EXPANDING STENT OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL 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. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) STATES THE FOLLOWING: ¿HOLD THE HUB END STATIONARY AND SLOWLY PULL THE HANDLE (A) TOWARD THE HUB (B)¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. 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: 1. IT APPEARS THE PHYSICIAN WAS TREATING AN AREA OF VASCULAR INJURY/RUPTURE INVOLVING THE LEFT COMMON ILIAC VEIN, THE CAUSE OF THE INJURY WAS NOT DISCUSSED. 2. THE AREA OF VASCULAR IRREGULARITY DID NOT APPEAR TO INVOLVE THE CONFLUENCE OF THE ILIAC VEINS AND THE IVC, BUT RATHER THE MID PORTION OF THE COMMON ILIAC VEIN. GIVEN THE LOCATION OF THE IRREGULARITY, THERE WAS NO INDICATION TO EXTEND THE STENT INTO THE IVC. 3. DURING DEPLOYMENT, THE PHYSICIAN DESCRIBES THE DELIVERY SYSTEM AS GETTING ¿STUCK¿ WHICH CAUSED THE STENT TO ¿JUMP FORWARD¿ RESULTING IN A MORE CENTRAL DEPLOYMENT THAN WAS ORIGINALLY INTENDED. THERE WAS REPORTEDLY NO SLACK IN THE SYSTEM OR ISSUES WITH ADVANCING THE DELIVERY SYSTEM IN PLACE. 4. WITHOUT ADDITIONAL INFORMATION REGARDING THE STEPS OF DEPLOYMENT, AND/OR VIDEO OF THE BEHAVIOR OF THE SYSTEM, ONE CAN ONLY HYPOTHESIZE ABOUT THE POTENTIAL CAUSES OF THIS REPORTED ISSUE BUT INCLUDES DEVICE MALFUNCTION AND PHYSICIAN RELATED ISSUES. 5. FORTUNATELY, THE END LOCATION OF THE STENT SHOULD HAVE NO CLINICAL IMPLICATIONS AS IT IS THE DESIRED LOCATION FOR STENT PLACEMENT WHEN TREATING OTHER VENOUS PATHOLOGIES SUCH AS MAY-THURNER SYNDROME. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. FROM THE IMAGING REVIEW, A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A DEVICE MALFUNCTION AND/OR DEVICE HANDLING. FROM THE INFORMATION AVAILABLE, IT IS KNOWN THAT THE PATIENT WAS BEEN TREATED FOR VENOUS INJURY. HOWEVER, IT IS NOT KNOWN WHAT TYPE OF INJURY THIS WAS. DEPENDING ON THE TYPE OF VENOUS INJURY, THE PATIENT¿S ANATOMY MAY HAVE EXERTED PRESSURE/STRESS/COMPRESSION ON THE DELIVERY SYSTEM, LEADING TO THE HANDLE STICKING AND SUBSEQUENTLY LEADING TO THE STENT JUMPING ON DEPLOYMENT. VENOUS INJURIES CAN VARY IN NATURE, AND CERTAIN ANATOMIES CAN EXACERBATE THE STRESSES ON MEDICAL DEVICES, LEADING TO UNEXPECTED DIFFICULTIES DURING PROCEDURES. OTHER POSSIBLE ROOT CAUSES COULD BE THE PLACEMENT OF THE DELIVERY SYSTEM AT THE TARGET LOCATION, THE ANGLE OF INSERTION OR THE HANDLING THE DELIVERY SYSTEM. AS PER THE USER, THE DELIVERY SYSTEM WAS NOT POSITIONED STRAIGHT AT THE LOCATION PRIOR TO DEPLOYMENT. IFU0091 STATES TO ¿BEFORE DEPLOYMENT, IT IS IMPORTANT TO STRAIGHTEN THE PROXIMAL PART OF THE DELIVERY SYSTEM AS MUCH AS POSSIBLE¿. THIS MIGHT HAVE CAUSED THE HANDLE TO STICK, LEADING TO THE STENT JUMPING FORWARD. IT IS ALSO POSSIBLE THAT WHEN THE HANDLE GOT STUCK, THE DELIVERY SYSTEM/HUB COULD HAVE BEEN INADVERTENTLY PUSHED LEADING TO THE STENT JUMPING. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. ATTEMPTS WERE MADE TO CONFIRM THAT THE DEVICE WAS BEING USED TO TREAT AN OBSTRUCTION HOWEVER IT WAS NOT CLEAR FROM THE INFORMATION PROVIDED. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF 01 X USED DEVICE. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, PATIENT OUTCOME WAS SATISFACTORY.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: THE DOCTOR COMPLAINED THAT THE VENA DELIVERY SYSTEM GOT STUCK AND STENT JUMPED FORWARD. WAS THE APPROACH? ACCESS SITE: LEFT FEM VEIN. HAD THE SHEATH/DILATOR KINK OR WERE THEY DAMAGED IN ANY WAY DURING ADVANCEMENT? NO. THE STENT JUMPED, BUT WAS IT SUCCESSFULLY PLACED? NO, BECAUSE IT EXTENDED BEYOND THE START OF THE VEIN BUT DID NOT OCCLUDE OTHER ILIAC VEIN. WHAT IS PATIENT OUTCOME? SATISFACTORY. PLEASE ADVISE IF THE DEVICE WILL BE RETURNED FOR INVESTIGATION. NO, DEVICE WAS NOT KEPT.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 5 JUN 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843551 ZILVER VENA VENOUS SELF EXPANDING STENT QAN - STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown