BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 1990915 · Received February 9, 2011

    Report

    Report Number
    3001845648-2011-00006
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 13, 2011
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WE ARE UNABLE TO DETERMINE IF THERE ARE ANY PRODUCTS OF THE SAME LOT NUMBER IN STOCK AS THE PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED ARE UNK. THE PART NUMBER AND LOT NUMBER OF THE DEVICES ARE UNK; THEREFORE, IT IS NOT POSSIBLE TO REVIEW THE MANUFACTURING RECORDS OR TO CONDUCT A SAMPLE TEST. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A POSSIBLE CAUSE OF THIS COMPLAINT MAY BE ATTRIBUTED TO PT ANATOMY AND PROGRESSION OF DISEASE. THE STENT WAS REMOVED SUCCESSFULLY AFTER BEING IMPLANTED FOR 12 MONTHS AND REPLACED WITH ANOTHER METAL STENT IN A DIFFERENCE LOCATION. WE HAVE BEEN INFORMED THAT THE PT REQUIRED A PERC AS A RESULT OF THIS OCCURRENCE. NO SECTION OF THE DEVICE REMAINED INSIDE THAT PT'S BODY. THE PT HAS NOT SUFFERED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND IS CONFIRMED TO CURRENTLY BE DOING FINE. IT IS NOT POSSIBLE TO SUGGEST A POSSIBLE ROOT CAUSE WITH SUCH LIMITED COMPLAINT INFO AVAILABLE. THE RESONANCE METALLIC STENTS ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PTS WITH EXTRINSIC URETERAL OBSTRUCTION. THESE DEVICES ARE INTENDED FOR ONE-TIME USE. IT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE THAT "PT SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY." A CAUTION ON THE INSTRUCTION FOR USE ADVISES THE FOLLOWING: "COMPLICATIONS OF URETERAL STENT PLACEMENT ARE DOCUMENTED. USE OF THIS DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PT. INFORMED CONSENT SHOULD BE OBTAINED TO MAXIMIZE PT COMPLIANCE WITH FOLLOW-UP PROCEDURES." OTHER CAUTIONS ON THE INSTRUCTIONS FOR USE INCLUDE: "THESE STENT ARE NOT INTENDED AS PERMANENT INDWELLING DEVICES." "THE STENT MUST NOT REMAIN INDWELLING MORE THAN TWELVE (12) MONTHS. IF THE PT'S STATUS PERMITS, THE STENT MAY BE REPLACED WITH A NEW STENT". "IMPROPER HANDLING OF THE STENT PRIOR TO INSERTION INTO THE URETER MAY HARM THE FUNCTIONALITY OF THE STENT. BENDING, STRETCHING OR ANY OTHER TYPE OF IMPROPER HANDLING MAY DEFORM THE STENT. IT IS IMPORTANT THAT THE STENT IS HANDLED WITH CARE." "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE". A 2 YEAR REVIEW OF THE COMPLAINT'S HISTORY REVEALED THAT THIS IS AN ISOLATED INCIDENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME BECAUSE THIS REPORT WAS UNABLE TO BE VERIFIED. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE TIP OF THE METAL STENT ERODED AND LODGED INTO HER RENAL PELVIS. THEY REPLACED IT WITH ANOTHER METAL STENT IN A DIFFERENT LOCATION. THE PT WAS NOTED TO THEN NEED A PERC. NO SECTION OF THE DEVICE REMAINED INSIDE THAT PT'S BODY. AN ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. STENT WAS RETRIEVED BY PCNL. THE PT HAS NOT SUFFERED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AND IS CONFIRMED TO CURRENTLY BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention