BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 2102248 · Received April 11, 2011

    Report

    Report Number
    3001845648-2011-00018
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    PMA / PMN Number
    P050017/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) #: P050017/S003. THERE WERE NO ZIV6-35-80-8-60 DEVICES OF LOT NUMBER C627223 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT DESCRIPTION CONTAINED THE FOLLOWING INFORMATION: "FOLLOWING INITIAL STENT PLACEMENT IN THE SUBCLAVIAN VEIN ON (B)(6) 2011, A PATIENT RETURNED ON (B)(6) 2011 FOR ANOTHER PROCEDURE. UPON FLUORO, IT WAS NOTED THAT THE STENT HAD PARTIALLY FRACTURED..." THE DEVICE INVOLVED IN THIS COMPLAINT IS A ZIV6-35-80-8-60 DEVICE. THIS IS A ZILVER VASCULAR STENT AND THE IFU WHICH ACCOMPANIES THIS DEVICE, IFU0043-6, CONTAINS THE FOLLOWING TEXT: "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 100 MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9MM." THIS EVENT CAN BE DESCRIBED AS OFF LABEL USE BASED ON THE INFORMATION PROVIDED. PRIOR TO DISTRIBUTION ALL ZIV6-35-80-8-60 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS BASED ON THE INFORMATION PROVIDED THIS COMPLAINT APPEARS TO BE DUE TO USER ERROR. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND IT IS BELIEVED THAT THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE.

    Description of Event or Problem · 1

    FOLLOWING INITIAL STENT PLACEMENT IN THE SUBCLAVIAN VEIN ON (B)(6) 2011, THE PATIENT RETURNED ON (B)(6) 2011 FOR ANOTHER PROCEDURE. THE STENT WAS IN THE SUBCLAVIAN VEIN AS THE PHYSICIAN HAD PLACED IT AFTER ANGIOPLASTY HAD FAILED IN THE PAST. WHILE OFF-LABEL, HE FELT THIS WAS THE BEST OPTION FOR THE PATIENT. UPON FLUORO, IT WAS NOTED THAT THE STENT HAD PARTIALLY FRACTURED. THE DECISION WAS MADE TO LEAVE THE STENT AT THIS TIME AS THE STENT WAS PARTIALLY FRACTURED BUT STILL INTACT AND TO USE THE OTHER ARM FOR FUTURE DIALYSIS TREATMENT. THE PATIENT IS DOING OKAY AT THIS MOMENT. THE STENT IS NOT GOING TO BE REMOVED AS PHYSICIAN BELIEVES IT WILL NOT FRACTURE ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C627223

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR