BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 24027293 · Received January 9, 2026

    Report

    Report Number
    3001845648-2026-00023
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 18, 2025
    Report Date
    February 17, 2026
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002438436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4- P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS

    Additional Manufacturer Narrative · 0

    G4- P050017/S002 AND S003. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF LOT C2356200 OF ZIV6-35-125-10-80 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. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL: THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE INSTRUCTIONS FOR USE, IFU0043 WHICH INFORMS THE USER ABOUT INDICATIONS FOR USE "THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9MM. PATIENTS SHOULD BE SUITABLE CANDIDATES FOR PTA AND/OR STENT TREATMENT¿. AS PER MEDICAL ADVISOR USING THIS DEVICE IN VENOUS STENT PLACEMENT IS AN OFF LABEL/ABNORMAL USE. ENGINEERING WAS CONTACTED TO CHECK IF THE OFF LABEL/ABNORMAL USE OF USING THIS DEVICE IN VENOUS STENT PLACEMENT WOULD HAVE CAUSED THE COMPLAINT ISSUE AND THEY CONFIRMED THAT ITS POSSIBLE THAT THE OFF LABEL/ABNORMAL USE CAUSED THE DEVICE FAILURE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO ABNORMAL USE. AS PER MEDICAL ADVISOR USING THIS DEVICE IN VENOUS STENT PLACEMENT IS AN OFF LABEL/ABNORMAL USE AND ENGINEERING HAVE CONFIRMED THAT ITS POSSIBLE THAT THE OFF LABEL/ABNORMAL USE CAUSED THE DEVICE FAILURE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT. AFTER DEPLOYING THE STENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. PATIENT OUTCOME. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 17-FEB-2026. AFTER DEPLOYING THE STENT, A PIECE OF THE INNER CATHETER BROKE OFF. THEY USED A SNARE TO PULL OUT THE PIECE OF THE BROKEN CATHETER. 1. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? 6 FRENCH BUT NOT SURE OF THE EXACT NAME. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? NOT ANSWERED. 3. CAN YOU PLEASE CLARIFY WHAT PIECE OF THE INNER CATHETER BROKE OFF? IF YOU CAN SHARE A IMAGE, IT WILL BE VERY HELPFUL FOR INVESTIGATION. VENOUS SINUS. THE INNER WIRE CANNULA BROKE. 4. DID THE USER OBSERVE ANY ISSUE THAT MAY CAUSE THIS TO HAPPEN? NO. 5. WAS THE DEVICE USED PERCUTANEOUSLY? YES. 6. WHAT WAS THE ACCESS SITE CHOSEN? FEMORAL VEIN. 7. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? .035 BENTSON. 8. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO. 9. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED, CALCIFIED, FIBRIOTIC)? (IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE). VERY TORTUOUS. 10. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? N/A, ISPILATERAL, CONTRALATERAL (IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO). N/A. 11. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G., KINK)? N/A, YES, NO (IF YES, PLEASE SPECIFY WHAT ADDITIONAL DEFECT(S) WERE OBSERVED AND WHERE ON THE DEVICE THIS WAS OBSERVED). NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233975 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO,STENT, ILIAC NIO COOK IRELAND LTD G43843 C2356200 10827002438436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female