BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VASCULAR SELF-EXPANDING STENT

    MDR report key: 18363906 · Received December 20, 2023

    Report

    Report Number
    3001845648-2023-00935
    Event Type
    Injury
    Date Received
    December 20, 2023
    Report Date
    July 22, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S002 AND S003. THIS FILE WAS CREATED FROM THE ATTACHED ZILVER VASCULAR FINAL PMCF REPORT (B)(4) PARTY VENDOR (FIVOS AND THE SOCIETY FOR VASCULAR SURGERY (SVS) PATIENT SAFETY ORGANIZATION) TO CAPTURE BELOW ADVERSE EVENTS AT DISCHARGE: -THROMBOSIS. -EMBOLIZATION. -TARGET LESION DISSECTION. -REMOTE ARTERY DISSECTION. -ARTERY PERFORATION. -HEMATOMA. -PSEUDOANEURYSM. -INFECTION. -A-V FISTULA. -STENOSIS/OCCLUSION. -STENOSIS > 30% OR 10MM GRADIENT. THIS FILE IS RELATED TO PR (B)(4) (3001845648-2023-00934), (B)(4) (3001845648-2023-00936). DEVICE EVALUATION: THE ZILVER VASCULAR SELF-EXPANDING STENT OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZILVER VASCULAR SELF-EXPANDING STENT 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 WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0043) LISTS THE FOLLOWING AS POTENTIAL ADVERSE EVENTS: -THROMBOSIS -EMBOLIZATION -TARGET LESION DISSECTION -REMOTE ARTERY DISSECTION -ARTERY PERFORATION -HEMATOMA -PSEUDOANEURYSM -INFECTION -A-V FISTULA -STENOSIS/OCCLUSION -STENOSIS > 30% OR 10MM GRADIENT. IT SHOULD BE NOTED THAT THROMBOSIS IS LISTED AS A POTENTIAL ADVERSE EVENT OF THIS DEVICE IN THE BENEFIT RISK ANALYSIS (B)(4) FOR ZILVER VASCULAR SELF-EXPANDING STENT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT'S PRE-EXISTING CONDITION OF CHRONIC PERIPHERAL ARTERIAL DISEASE AS NO SIGNIFICANT DIFFERENCES WERE NOTED IN THE STUDY BETWEEN COOK ZILVER VASCULAR SELF EXPANDING STENTS AND ALL OTHER BARE METAL STENTS. AS PREVIOUSLY NOTED, THE LISTED ADVERSE EVENTS AT DISCHARGE ARE LISTED AS KNOWN POTENTIAL ADVERSE EVENTS WITHIN THE IFU AND ARE KNOWN ADVERSE EVENTS OF PERIPHERAL VASCULAR INTERVENTION PROCEDURES THAT CAN BE CAUSED BY CHRONIC PERIPHERAL ARTERIAL DISEASE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY: THIS FILE WAS CREATED FROM A PMCF STUDY. IN ORDER TO EVALUATE THE COOK MEDICAL BARE METAL ZILVER VASCULAR SES, VQI PERIPHERAL VASCULAR INTERVENTION (PVI) REGISTRY DATA FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2017 AND (B)(6) 2023 BY PHYSICIANS PARTICIPATING IN THE VQI PVI REGISTRY WERE ANALYZED. ALL CONSECUTIVE PVI PROCEDURES FOR TREATMENT OF CHRONIC PERIPHERAL ARTERIAL DISEASE WERE SELECTED. CONFIRMED QUANTITY OF (B)(4) DEVICES, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED IN (B)(4) CASES. ALL PATIENTS WOULD HAVE REQUIRED INTERVENTION/ADDITIONAL PROCEDURES. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE OF PATIENTS PRE EXISTING CONDITIONS. ADVERSE EVENTS LISTED AT DISCHARGE ARE LISTED WITHIN THE IFU AND ARE KNOWN ADVERSE EVENTS OF PERIPHERAL VASCULAR INTERVENTION PROCEDURES THAT CAN BE CAUSED BY CHRONIC PERIPHERAL ARTERIAL DISEASE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JUL-2024.

    Description of Event or Problem · 0

    ZILVER VASCULAR FINAL PMCF REPORT MDR-2058_3RD PARTY VENDOR (FIVOS AND THE SOCIETY FOR VASCULAR SURGERY (SVS) PATIENT SAFETY ORGANIZATION) METHODS: IN ORDER TO EVALUATE THE COOK MEDICAL BARE METAL ZILVER VASCULAR SES, VQI PERIPHERAL VASCULAR INTERVENTION (PVI) REGISTRY DATA FOR PROCEDURES PERFORMED BETWEEN JANUARY 2017 AND APRIL 2023 BY PHYSICIANS PARTICIPATING IN THE VQI PVI REGISTRY WERE ANALYZED. ALL CONSECUTIVE PVI PROCEDURES FOR TREATMENT OF CHRONIC PERIPHERAL ARTERIAL DISEASE WERE SELECTED. THIS FILE CAPTURES BELOW ADVERSE EVENTS AT DISCHARGE: -THROMBOSIS -EMBOLIZATION -TARGET LESION DISSECTION -REMOTE ARTERY DISSECTION -ARTERY PERFORATION -HEMATOMA -PSEUDOANEURYSM -INFECTION -A-V FISTULA -STENOSIS/OCCLUSION -STENOSIS > 30% OR 10MM GRADIENT PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4 PATIENT/EVENT INFO: TOTAL NUMBER OF PROCEDURES = 1674; TOTAL NUMBER OF PATIENTS = 1596 (MALE = 1032), AVG AGE = 68.2 YRS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106336 ZILVER VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention