BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX VASCULAR SELF-EXPANDING STENT

    MDR report key: 22158349 · Received June 6, 2025

    Report

    Report Number
    3001845648-2025-00265
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    June 5, 2024
    Report Date
    July 24, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    PMA / PMN Number
    P050017/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K#: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510K#: P050017/S002 AND S003 DEVICE EVALUATION: THE ZILVER FLEX VASCULAR 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. THIS FILE WAS CREATED IN RESPONSE TO A LITERATURE STUDY. 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. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058) STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION PROVIDED, THE DEVICE WAS USED IN THE SUPERIOR MESENTERIC VEIN. AS PREVIOUSLY NOTED, THE IFU STATES ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE-THE-KNEE POPLITEAL ARTERY¿. THE ABNORMAL USE RESULTED IN STENT THROMBOSIS AT 1 YEAR. 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. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. 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: THIS COMPLAINT WAS OPENED FROM LITERATURE STUDY GRASU ET AL, 'CASE REPORT AIMS TO CONTRIBUTE TO THE UNDERSTANDING OF THE ROLE OF STENTING AS A THERAPEUTIC OPTION FOR IDIOPATHIC SMV STENOSIS, ADDRESSING A SIGNIFICANT GAP IN THE CURRENT MEDICAL LITERATURE' TO CAPTURE 01 CASE OF ABNORMAL USE RESULTING IN STENT THROMBOSIS REQUIRING INTERVENTION. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    GRASU ET AL ¿ 2024 - CASE REPORT AIMS TO CONTRIBUTE TO THE UNDERSTANDING OF THE ROLE OF STENTING AS A THERAPEUTIC OPTION FOR IDIOPATHIC SMV STENOSIS, ADDRESSING A SIGNIFICANT GAP IN THE CURRENT MEDICAL LITERATURE. THE SUBSEQUENT INTERVENTION INVOLVED THE PLACEMENT OF AN 8 MM SELF-EXPANDING STENT WITH A 40 MM LENGTH (ZILVER FLEX® VASCULAR SELF-EXPANDING STENT¿COOK MEDICAL, BLOOMINGTON, IN, USA) ACROSS THE IDENTIFIED STENOSIS. THE CONTROL VENOGRAPHY SHOWED AN IMPROVED FLOW INTO THE PORTAL VEIN. ONE WEEK POST-PROCEDURE, THE CT SCAN CONFIRMED STENT PATENCY AND DEMONSTRATED A SIGNIFICANT REDUCTION IN COLLATERAL VESSELS. AT ONE MONTH, THE PATIENT UNDERWENT FOLLOW-UP UPPER ENDOSCOPY, WHICH CERTIFIED THE OUTSTANDING OUTCOME OF THE PROCEDURE, EVIDENCED BY THE RESOLUTION OF THE LARGE ECTATIC VEINS IN THE STOMACH. ONE YEAR FOLLOWING THE PROCEDURE, SUBSEQUENT UPPER ENDOSCOPY REVEALED THE DEVELOPMENT OF NOVEL GASTRIC VARICES. IN ACCORDANCE WITH THE ESTABLISHED FOLLOW-UP PROTOCOL, A SUBSEQUENT MDCT ANGIOGRAPHY WAS PERFORMED. THE IMAGING FINDINGS INDICATED PARTIAL THROMBOSIS WITHIN THE STENT AND VENOUS COLLATERAL VESSELS USING THE TRANSHEPATIC APPROACH, IN A SIMILAR MANNER AS THE INITIAL PROCEDURE, THE VENOGRAPHY WAS PERFORMED, AND THE THROMBOSIS OF THE STENT WAS CONFIRMED. THE STENT UNDERWENT DILATION, FOLLOWED BY THE DEPLOYMENT OF A NEW 8 MM SELF-EXPANDING STENT (ZILVER FLEX® VASCULAR SELF-EXPANDING STENT¿COOK MEDICAL, BLOOMINGTON, IN, USA), ENSURING A 7 MM OVERLAP WITH THE PRE-EXISTING STENT, AT THE END OF THE PROCEDURE, WE ACHIEVED AN OPTIMAL FLOW WITHIN THE PORTAL VEIN. THIS COMPLAINT WILL CAPTURE THROMBOSIS REQUIRING INTERVENTION. IT CAN ALSO BE NOTED THAT THE USE OF THE ZILVER FLEX VASCULAR SELF-EXPANDING STENT IN THE SMV (SUPERIOR MESENTERIC VEIN) IS OFF-LABEL USE OF THE DEVICE. THE PATIENT REQUIRED INTERVENTION.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-JUL-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618711 ZILVER FLEX VASCULAR SELF-EXPANDING STENT NIO - STENTS, ILIAC NIO COOK IRELAND LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention