BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    MDR report key: 11730310 · Received April 27, 2021

    Report

    Report Number
    3001845648-2021-00334
    Event Type
    Injury
    Date Received
    April 27, 2021
    Report Date
    July 16, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. THE ZILVER 518 VASCULAR SELF-EXPANDING STENT DEVICE OF AN 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. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 518 VASCULAR SELF-EXPANDING STENT DEVICES ARE SUBJECT TO VISUAL 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 (IFU0043-9) STATES THE FOLLOWING: INDICATIONS FOR USE 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 UP TO 100MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9MM. THE INSTRUCTIONS FOR USE ALSO OUTLINE THE FOLLOWING: INSTRUCTIONS FOR USE 2. INTRODUCE THE EXTRA OR ULTRA-STIFF WIRE GUIDE (7.0 AND 6.0 FRENCH [2.3 AND 2.00MM] SYSTEMS ACCEPT 0.035 INCH [0.89 MM] WIRE GUIDE; 5.0 FRENCH [1.67 MM] SYSTEM ACCEPTS 0.018 INCH [0.46MM] WIRE GUIDE) THROUGH THE ACCESS CATHETER ACROSS THE DISTAL SEGMENT OF THE TARGET LESION. THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS KNOWN THAT THE PROCEDURE BEING CARRIED OUT WAS CEREBRAL VENOUS SINUS STENTING. ALSO, ACCORDING TO THE CUSTOMER TESTIMONY A 0.14 WIRE GUIDE WAS USED TO CARRY OUT THE PROCEDURE. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. ZILVER 518 VASCULAR SELF-EXPANDING STENT DEVICES ARE INTENDED FOR USE IN THE ILIAC ARTERIES. IT IS KNOWN THAT THE PROCEDURE BEING CARRIED OUT WAS CEREBRAL VENOUS SINUS STENTING. IN ADDITION, USER ERROR WAS IDENTIFIED. A 0.14 WIRE GUIDE WAS USED FOR THE PROCEDURE. ZILVER 518 VASCULAR SELF-EXPANDING STENT DEVICES ARE DESIGNED TO BE USED WITH A 0.18¿ WIRE GUIDE. IT IS POSSIBLE THAT USE IN A LOCATION OTHER THAN SPECIFIED WITHIN THE IFU AND THE USE OF 0.14 WIREGUIDE CREATED THE NEED TO USE AN ADDITIONAL STENT TO TREAT THE DISSECTION. IT IS NOT POSSIBLE TO STATE HOW THE DEVICE WILL PERFORM WHEN USED OUTSIDE OF ITS VALIDATED STATE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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

    THE INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    PER COMPLAINT FORM DISSECTION OF ? VENOUS SINUS. DISSECTION CREATED THE NEED TO USE AN ADDITIONAL STENT TO TREAT THE DISSECTION. PER REP (B)(6) 2021 THE DOCTOR WAS USING AN .014 WIRE THROUGH THE DEVICE. HE WAS UP IN ONE OF THE VENOUS SINUSES IN THE BRAIN. 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? YES / INTERVENTION DURING ORIGINAL PROCEDURE. IF YES, PLEASE DESCRIBE. DISSECTION CREATED THE NEED TO USE AN ADDITIONAL STENT TO TREAT THE DISSECTION. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES / INTERVENTION DURING ORIGINAL PROCEDURE. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. DISSECTION CREATED THE NEED TO USE AN ADDITIONAL STENT TO TREAT THE DISSECTION. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631623 ZILVER 518 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention