BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 19526622 · Received June 13, 2024

    Report

    Report Number
    3001845648-2024-00273
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Report Date
    August 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    PMA/510(K) # P200023. THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, KELLY 2023 - RECANALIZATION OF INFERIOR VENA CAVA AND BILATERAL ILIAC VEINS 15 YEARS AFTER MAY¿THURNER SYNDROME-RELATED OCCLUSION. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE ZILVER VENA DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: 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. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL: THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTION FOR USE. THE DEVICE IFU0091 STATES THAT THE DEVICE ¿IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL OUTFLOW OBSTRUCTION¿. THE STENTS WERE PLACED ¿TOO HIGH (IVC FILTER WAS PLACED JUST BELOW RENAL VEINS AND THE STENTS PLACED JUST BELOW LEVEL OF IVC FILTER)¿. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS ESTABLISHED. ACCORDING TO THE ARTICLE ¿THE STENTS WERE PASSED UP TO JUST BELOW THE LEVEL OF THE IVC FILTER LEVEL¿. THIS PLACEMENT IS TOO HIGH AND IS CONSIDERED OFF LABEL USE FOR THE DEVICE, AS PER MEDICAL ADVISOR INPUT. THE DEVICE WAS USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICE WILL PERFORM OR FUNCTION. AS PER (B)(4), SECTION 5.3 TABLE 1 - OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION: FOR ALL COMPLAINTS A RECOMMENDED ACTION WILL BE TO MONITOR FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO THE ATTACHED LITERATURE ARTICLE, KELLY 2023 - RECANALIZATION OF INFERIOR VENA CAVA AND BILATERAL ILIAC VEINS 15 YEARS AFTER MAY¿THURNER SYNDROME-RELATED OCCLUSION. CONFIRMED QUANTITY OF (B)(4) DEVICES USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS DETERMINED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: AS INITIALLY REPORTED TO CUSTOMER RELATIONS: KELLY 2023 - RECANALIZATION OF INFERIOR VENA CAVA AND BILATERAL ILIAC VEINS 15 YEARS AFTER MAY¿THURNER SYNDROME-RELATED OCCLUSION AFTER VENOPLASTY, WE PERFORMED BILATERAL ILIAC VEIN INTRAVASCULAR ULTRASOUND (IVUS) TO CONFIRM THE LEFT COMMON ILIAC VEIN COMPRESSION AND SIZE THE LARGER SEGMENTS OF THE ILIAC VEINS TO OPTIMIZE STENT DIAMETER SELECTION. WE NEXT, UP BOTH THE RIGHT- AND LEFT-SIDED SHEATH, INSERTED 14 MM DIAMETER ZILVER VENA (COOK MEDICAL) STENTS. THE STENTS WERE PASSED UP TO JUST BELOW THE LEVEL OF THE IVC FILTER LEVEL. THEY WERE SIMULTANEOUSLY DEPLOYED IN A KISSING FASHION SUCH THAT THEY EXTENDED ON THE RIGHT SIDE INTO THE COMMON ILIAC VEIN AND ON THE LEFT SIDE TO THE EXTERNAL ILIAC VEIN. AFTER THE STENTS WERE DEPLOYED OVER THE WIRE, WE THEN INSERTED A 12 MM DIAMETER BY 4 CM LENGTH ANGIOPLASTY BALLOON WITH OVERINFLATION TO 16 ATM TO ACHIEVE FULL ANGIOPLASTY PROFILE OF THE STENTS. SEQUENTIAL BILATERAL VENOPLASTY WAS PERFORMED IN A KISSING FASHION FROM THE DOUBLE BARREL IVC LEVEL ALL THE WAY DOWN TO THE COMMON ILIAC LEVEL ON THE RIGHT AND THE EXTERNAL ILIAC VEIN LEVEL ON THE LEFT. THE FINAL COMPLETION VENOGRAMAFTER DOUBLE BARREL STENTING OF THE ILIAC VENOUS SYSTEM REVEALED WIDELY PATENT BILATERAL ILIAC VENOUS SYSTEM WITHOUT ANY EVIDENCE OF RESIDUAL STENOSIS AND BRISK FLOW INTO THE IVC THROUGH THE FILTER ULTIMATELY DRAINING TO THE RIGHT ATRIUM. OFF-LABEL USE: 2 X 14MM ZILVER VENA STENTS WERE PLACED TOO HIGH (IVC FILTER WAS PLACED JUST BELOW RENAL VEINS AND THE STENTS PLACED JUST BELOW LEVEL OF IVC FILTER)

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 23-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184246 ZILVER VENA VENOUS SELF-EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male