BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    MDR report key: 15111594 · Received July 27, 2022

    Report

    Report Number
    3001845648-2022-00476
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    September 17, 2021
    Report Date
    February 8, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    PMA/510(K) #P050017/S006. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER FLEX 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058) LISTS ¿ARTERIAL ANEURYSM¿ AND ¿HEMATOMA/HAEMORRHAGE¿ AS POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS OF THE PROCEDURE. AS PER MEDICAL ADVISOR INPUT ¿HAEMATOMA AND PSEUDOANEURYSM FORMATION ARE KNOWN COMPLICATIONS OF ARTERIAL VASCULAR STENT PLACEMENT¿. IT SHOULD BE NOTED THAT THE IFU LISTS ARTERIAL ANEURYSM AND HEMATOMA AS POTENTIAL ADVERSE EVENTS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER PINTO ET AL ¿ENDOVASCULAR MANAGEMENT OF TRANSPLANT RENAL ARTERY STENOSIS: EARLY AND MID-TERM RESULTS¿. ACCORDING TO THE INITIAL REPORTER, THERE WERE 02 ACCESS-RELATED COMPLICATIONS: 01 GROIN HEMATOMA THAT WAS SURGICALLY DRAINED AND 01 COMMON FEMORAL ARTERY FALSE ANEURISM TREATED WITH ECO-GUIDED THROMBIN EMBOLIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZILVER FLEX 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0058) LISTS ¿ARTERIAL ANEURYSM¿ AND ¿HEMATOMA/HAEMORRHAGE¿ AS POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS OF THE PROCEDURE. AS PER MEDICAL ADVISOR INPUT ¿HAEMATOMA AND PSEUDOANEURYSM FORMATION ARE KNOWN COMPLICATIONS OF ARTERIAL VASCULAR STENT PLACEMENT¿. IT SHOULD BE NOTED THAT THE IFU LISTS ARTERIAL ANEURYSM AND HEMATOMA AS POTENTIAL ADVERSE EVENTS. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER PINTO ET AL ¿ENDOVASCULAR MANAGEMENT OF TRANSPLANT RENAL ARTERY STENOSIS: EARLY AND MID-TERM RESULTS¿. ACCORDING TO THE INITIAL REPORTER, THERE WERE 02 ACCESS-RELATED COMPLICATIONS: 01 GROIN HEMATOMA THAT WAS SURGICALLY DRAINED AND 01 COMMON FEMORAL ARTERY FALSE ANEURISM TREATED WITH ECO-GUIDED THROMBIN EMBOLIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PINTO ET AL 2021 ¿ ¿ENDOVASCULAR MANAGEMENT OF TRANSPLANT RENAL ARTERY STENOSIS: EARLY AND MID-TERM RESULTS¿. IN CASES OF MORE SIGNIFICANT STENOSIS, ARTERY PRE-DILATION WITH BALLOON ANGIOPLASTY IS PERFORMED. DIFFERENT TYPES OF STENTS ARE USED ACCORDING TO THE AFFECTED ARTERY AND AVAILABILITY: SELF-EXPANDING STENTS ZILVER FLEX¿ (COOK MEDICAL, (B)(4)) AND ABSOLUT PRO¿ (ABBOTT VASCULAR, (B)(4)) ARE USED IN THE EXTERNAL ILIAC ARTERIES. ANGIOPLASTY WITH SELF-EXPANDABLE STENT PLACEMENT IN THE EXTERNAL ILIAC ARTERY (2/13) IN TWO. THERE WERE TWO ACCESS-RELATED COMPLICATIONS: A GROIN HEMATOMA THAT WAS SURGICALLY DRAINED AND A COMMON FEMORAL ARTERY FALSE ANEURISM TREATED WITH ECO-GUIDED THROMBIN EMBOLIZATION.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11NOV2022.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO AN UPDATE TO THE IMDRF CODING ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758580 ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization