BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 20664544 · Received November 12, 2024

    Report

    Report Number
    3001845648-2024-00650
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    March 13, 2024
    Report Date
    February 21, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002518602
    PMA / PMN Number
    P050017/S006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/ 510 K: P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE ZFV6-80-5-6.0 DEVICE OF LOT NUMBER C2033934 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT IS RELATED TO (B)(4) AND WAS RAISED FROM THE PMCF STUDY. MANUFACTURING RECORDS REVIEW: 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 REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058) LISTS THE FOLLOWING POTENTIAL ADVERSE EVENT: ¿RESTENOSIS OF THE STENTED ARTERY¿. THERE IS NO 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 COULD NOT BE DETERMINED. FROM THE STUDY, A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENT STOPPING THEIR ANTI PLATELET MEDICATION FOR 04 WEEKS. ALSO, AS PREVIOUSLY NOTED ¿RESTENOSIS OF THE STENTED ARTERY¿ IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF (B)(4) 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, THE PATIENT PRESENTED WITH WORSENING CLAUDICATION IN THE LEFT LOWER LEG, ULTRASOUND SHOWED A HIGH GRADE IN STENT STENOSIS. THE PATIENT REQUIRED INTERVENTION AS A RESULT OF THIS OCCURRENCE. THE PATIENT RECOVERED AND WAS DISCHARGED WITHOUT COMPLICATIONS. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO THE PATIENT STOPPING ANTI PLATELET MEDICATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024 DATE OF INITIAL PROCEDURE, 2 STUDY DEVICES PLACED IN LEFT STUDY LEG. NO ADVERSE EVENTS DURING THE PROCEDURE OR PRIOR TO DISCHARGE ON (B)(6) 2024 A PLANNED INTERIM APPOINTMENT AT THE VASCULAR SURGERY DEPARTMENT WAS SCHEDULED. PATIENT PRESENTED WITH AGAIN WORSENING CLAUDICATION IN THE LEFT LOWER LEG (STUDY LEG) DURING THE RECENT 4 WEEKS SINCE THE PATIENT STOPPED TAKING ANTI PLATELET MEDICATION TO HAVE A DENTAL SURGERY. DOPPLER ULTRASOUND SHOWED A HIGH GRADE INSTENT STENOSIS IN THE DISTAL STUDY STENT IN THE DISTAL SUPERFICIAL FEMORAL ARTERY LEFT. THERE WAS NO CRITICAL LIMB ISCHEMIA. THE PATIENT WANTED TO FIRST UNDERGO A PLANNED OPHTALMOLOGIC SURGERY. FINAL IN-PATIENT ADMISSION FOR RE-INTERVENTION WAS ON (B)(6) 2024. ENDOVASCULAR RE-INTERVENTION WAS PERFORMED ON THE SAME DAY WHERE A THEN TOTAL OCCLUSION OF THE LEFT AFS AND ALL STUDY STENTS WAS TREATED WITHOUT COMPLICATIONS. PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS ON (B)(6) 2024. 11 RELATIONSHIPS TO STUDY DEVICE(S) ¿ PROBABLE: 11.1 IF RELATED (POSSIBLE, PROBABLE, CAUSAL), PROVIDE A DETAILED DESCRIPTION OF HOW THE STUDY DEVICE(S) CAUSED OR CONTRIBUTED TO THIS EVENT: ALL RECOMMENDED ANTI PLATELET MEDICATION HAS BEEN STOPPED BY THE PATIENT WITHOUT OUR RECOMMENDATION TO DO SO TO HAVE DENTAL SURGERY. THE STUDY DEVICES WERE TOTALLY OCCLUDED. STOPPING THE ANTI-PLATELET MEDICATION FOR 4 WEEKS PROBABLY HAS LED TO THIS EVENT. 12 RELATIONSHIPS TO STUDY PROCEDURE ¿ PROBABLE 12.1 IF RELATED (POSSIBLE, PROBABLE, CAUSAL), PROVIDE A DETAILED DESCRIPTION OF HOW THE STUDY PROCEDURE CAUSED OR CONTRIBUTED TO THIS EVENT: WITHOUT THE STUDY PROCEDURE NO STUDY STENT CAN BE IMPLANTED. THE SUBINTIMAL RECANALIZATION MAY HAVE LED TO A GENERAL WORSE RECANALIZATION OUTCOME. OCCLUSION REQUIRING INTERVENTION RESOLVED ON (B)(6) 2024.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974649 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G51860 C2033934 10827002518602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention