BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    MDR report key: 12065400 · Received June 25, 2021

    Report

    Report Number
    3001845648-2021-00521
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 28, 2021
    Report Date
    September 3, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002437828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    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.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. DEVICE EVALUATION: THE ZIV5-18-125-8-60 DEVICE OF LOT NUMBER C1787927 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28TH JULY 2021. ON EVALUATION OF THE DEVICE, SEPARATION OF THE OUTER SHEATH FROM THE HANDLE WAS OBSERVED AT THE DISTAL END OF HANDLE, JUST BELOW THE WHITE CAP. THE DEVICE COULD NOT BE FLUSHED. A 0.018 INCH WIRE GUIDE COULD NOT PASS THROUGH THE DEVICE. BLOOD WAS OBSERVED ON DISTAL END OF INNER CATHETER. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIV5-18-125-8-60 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ZIV5-18-125-8-60 OF LOT NUMBER C1787927 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1787927. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0043-9) STATES THE FOLLOWING: ¿THE ZILVER VASCULAR STENT IS INTENDED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF- LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE USER USED THIS DEVICE FOR THE TREATMENT OF A LESION ON THE SFA. THIS IS CONSIDERED OFF LABEL USE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A STANDARD ANGIO PROCEDURE IN WHICH THE ZILVER 518 VASCULAR SELF-EXPANDING STENT, G43782, WAS USED. THE FLEXOR PART DISATTACHED FROM THE HANDLE THEREFORE THE STENT WAS NOT DEPLOYED. AS THE OTHER G43782 THE CUSTOMER HAD WAS THE SAME LOT NUMBER AND IT WAS NOT TRUSTED BY THE CUSTOMER THEY USED A DIFFERENT SIZE OF A ZILVER 518 TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE COMPLAINT DEVICE. DEVICE EVALUATED ON (B)(6) 2021: "SEPARATION OF OUTER SHEATH FROM HANDLE."

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961808 ZILVER 518 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G43782 C1787927 10827002437828

    Patients

    Seq Age Sex Outcome Treatment
    1