BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER SELF-EXPANDING VASCULAR STENT

    MDR report key: 10229442 · Received July 3, 2020

    Report

    Report Number
    3001845648-2020-00393
    Event Type
    Injury
    Date Received
    July 3, 2020
    Report Date
    April 3, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. DEVICE EVALUATION THE ZIV DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZIV DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0041-7) LISTS ISCHEMIA REQUIRING INTERVENTION (BYPASS OR AMPUTATION OF TOE, FOOT OR LEG) AS A KNOWN POTENTIAL ADVERSE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT PATIENT PRE-EXISTING CONDITIONS INCLUDED DIABETES, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), PREVIOUS MYOCARDIAL INFARCTION, END-STAGE RENAL DISEASE, CONGESTIVE HEART FAILURE (CHF) AND PERIPHERAL ARTERY DISEASE (PAD). AS PREVIOUSLY STATED, THE IFU LISTS ISCHEMIA REQUIRING INTERVENTION AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE DEVICE HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THE ZILVER DEVICES MALFUNCTIONED OR DETERIORATED IN PERFORMANCE CHARACTERISTICS DURING THIS STUDY. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE RETROGRADE INTERVENTION WAS PERFORMED TO TREAT ISCHEMIA. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. 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. THIS COMPLAINT WAS RAISED FROM ATTACHED ARTICLE KAUSHAL ET AL 2017: (ZILVER STENT) "OUTCOMES AT A SINGLE CENTER AFTER SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE-RETROGRADE INTERVENTION FOR CRITICAL LIMB ISCHEMIA" AND IS RELATED TO PR (B)(4). LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIV DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS 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 LISTS ISCHEMIA REQUIRING INTERVENTION (BYPASS OR AMPUTATION OF TOE, FOOT OR LEG) AS A KNOWN POTENTIAL ADVERSE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW. NO ROOT CAUSE REQUIRED AS THE COMPLAINT IS NOT CONFIRMED. THE SUBINTIMAL ARTERIAL FLOSSING TECHNIQUE IN CONJUNCTION WITH STENTING IN THIS ARTICLE WAS TO TREAT CRITICAL LIMB ISCHEMIA RATHER THAN CAUSING THE ISCHEMIA. THE COOK STENTS USED IN THIS STUDY WERE USED TO TREAT ALREADY EXISTING CRITICAL LIMB ISCHEMIA IN CONJUNCTION WITH BALLOON DILATION. THEY DID NOT CAUSE OR CONTRIBUTE TO THE CLI. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT PATIENT PRE-EXISTING CONDITIONS INCLUDED DIABETES, HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), PREVIOUS MYOCARDIAL INFARCTION, END-STAGE RENAL DISEASE, CONGESTIVE HEART FAILURE (CHF) AND PERIPHERAL ARTERY DISEASE (PAD). AS PREVIOUSLY STATED, THE IFU LISTS ISCHEMIA REQUIRING INTERVENTION AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE DEVICE HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THE ZILVER DEVICES MALFUNCTIONED OR DETERIORATED IN PERFORMANCE CHARACTERISTICS DURING THIS STUDY. SUMMARY. THE COMPLAINT CANNOT BE CONFIRMED BECAUSE THE DEVICE OR THE PROCEDURE HAVE NOT CAUSED OR CONTRIBUTED TO THE EVENTS REPORTED. THIS COMPLAINT WAS RAISED FROM ARTICLE KAUSHAL ET AL 2017: (ZILVER STENT) "OUTCOMES AT A SINGLE CENTER AFTER SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE-RETROGRADE INTERVENTION FOR CRITICAL LIMB ISCHEMIA" . ACCORDING TO THE INITIAL REPORTER, SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE RETROGRADE INTERVENTION WAS PERFORMED TO TREAT ISCHEMIA. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    A SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO CANCELLATION OF THE REPORT. UPDATED CLINICAL INPUT WAS RECEIVED AND FILE WAS REVIEWED BY QUALITY ENGINEERING COMPLAINT NO LONGER MEETS THE DEFINITION OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ THE SUBINTIMAL ARTERIAL FLOSSING TECHNIQUE IN CONJUNCTION WITH STENTING IN THIS ARTICLE WAS TO TREAT CRITICAL LIMB ISCHEMIA RATHER THAN CAUSING THE ISCHEMIA. THE COOK STENTS USED IN THIS STUDY WERE USED TO TREAT ALREADY EXISTING CRITICAL LIMB ISCHEMIA IN CONJUNCTION WITH BALLOON DILATION. THEY DID NOT CAUSE OR CONTRIBUTE TO THE CLI.

    Additional Manufacturer Narrative · 1

    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 · 1

    KAUSHAL ET AL 2017: (ZILVER STENT) "OUTCOMES AT A SINGLE CENTER AFTER SUBINTIMAL ARTERIAL FLOSSING WITH ANTEGRADE-RETROGRADE INTERVENTION FOR CRITICAL LIMB ISCHEMIA." 15 PATIENTS (28.8%) HAD ARTERIES THAT WERE STENTED. ALL OF THESE STENTS WERE SELF-EXPANDING STENTS, WHICH INCLUDED THE SUPERA STENT (ABBOTT, ABBOTT PARK, ILL), THE ZILVER STENT (COOK, BLOOMINGTON, IND), THE EPIC SFA STENT (BOSTON SCIENTIFIC, NATICK, MASS), THE PROTÉGÉ EVERFLEX STENT (MEDTRONIC, MINNEAPOLIS, MINN), AND THE INNOVA STENT. THIS FILE WILL CAPTURE THE POTENTIAL THAT COOK STENTS CAUSED CRITICAL LIMB ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692793 ZILVER SELF-EXPANDING VASCULAR STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention