BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 3223721 · Received July 9, 2013

    Report

    Report Number
    3001845648-2013-00062
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO RECEIVED IN THE COMPLAINT FORM CONFIRMED THE DEVICE INVOLVED IN THIS COMPLAINT TO BE AN RMS-0600XX-R DEVICE, THEREFORE RMS-060026-R HAS BEEN USED IN THIS COMPLAINT FOR LOGGING PURPOSES. THE LOT NUMBER OF THE RESONANCE METAL STENT WAS NOT PROVIDED; THEREFORE, IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT REMAINED IN STOCK. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVAL; THEREFORE, THE CUSTOMER REPORTED COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE FOLLOWING COMMENTS WERE RECEIVED FROM COOK INCORPORATED MEDICAL SCIENCE OFFICER IN RELATION TO THIS COMPLAINT "THE COMPLAINANT'S SUGGESTION THAT THE HEAVY BLEEDING MAY HAVE RESULTED FROM DEVELOPMENT OF AN ARTERIO-URETERIC FISTULA IS PLAUSIBLE. THIS IS A RECOGNIZED, ALBEIT SOMEWHAT RARE, COMPLICATION OF LONG-TERM URETERAL STENTS, INCLUDING THE RMS". A DEFINITIVE CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED AND THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED; HOWEVER, A POSSIBLE ROOT CAUSE AS PER THE DETAILS ABOVE BY THE PHYSICIAN SPECULATES THE BLEEDING WAS DUE TO THE STENT TUBING ALONG THE ILIAC VESSELS, POSSIBLY CAUSING THE TISSUE TO WEAKEN AND BECOME A FISTULA; HENCE, THE BLEEDING UPON REMOVAL. PRE-EXISTING PT CONDITIONS WAS METASTATIC BEAST CANCER. ANEMIC. THE DOCTOR NOTED HEMATURE APPROX 8 MONTHS TO 1 YEAR AGO, WHICH WAS WHY THE STENTS WERE SELECTED AS AN OPTION. PRIOR TO DISTRIBUTION, RESONANCE STENT DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED, IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE DEVICE MFG RECORDS FOR THIS DEVICE. THE RMS-060026-R DEVICES ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PTS WITH EXTRINSIC URETERAL OBSTRUCTION. THESE DEVICES ARE INTENDED FOR ONE-TIME USE. THESE STENTS ARE NOT INTENDED AS PERMANENT INDWELLING DEVICES AND MUST NOT REMAIN INDWELLING FOR MORE THAN 12 MONTHS AS OUTLINED IN THE IFU0020-12. THEREFORE, AS PER THE IFU INTERVENTION TO REMOVE / REPLACE THE RMS STENT IS STANDARD PROCEDURE. AS PER INSTRUCTIONS FOR USE, IFU0020-12, USERS ARE CAUTIONED AS FOLLOWS: "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 F/U PROCEDURES." A FINAL CAUTION INDICATES THAT: "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE." THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED ACROSS THE RMS PRODUCT FAMILY AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. THE OVERALL RISK ASSOCIATED WITH THIS FAILURE MODE HAS BEEN DETERMINED TO BE MODERATE. CUSTOMER QA WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    PER COMPLAINT FORM: APPROX SUMMER 2012, 2 METALIC STENTS WERE PLACED (ONE IN EACH URETER) IN PT. AFTER 6 MONTHS, THEY WERE CHECKED AND BOTH LOOKED FINE AND DRAINING. IN APPROX (B)(6) 2013, ONE METALLIC STENT WAS REMOVED AND REPLACED WITH BARD INLAY STENT. UPON REMOVAL, THERE WAS UNUSUALLY HEAVY BLEEDING. THE PHYSICIAN SPECULATES THE BLEEDING WAS DUE TO THE STENT RUBBING ALONG THE ILIAC VESSELS, POSSIBLY CAUSING THE TISSUE TO WEAKEN AND BECOME A FISTULA; HENCE, THE BLEEDING UPON REMOVAL. THE OTHER STENT REMAINED IN SITU SINCE IT LOOKED FINE. YESTERDAY, (B)(6) 12, THE SECOND METALLIC STENT WAS REMOVED WITH A SMALL BIT OF BLEEDING, BUT NOTHING THAT CAUSED ALARM OR CONCERN BY THE PHYSICIAN. THIS STENT WAS REPLACED BY A (B)(4) STENT. PER COMPLAINT FORM: DUE TO THE NATURE OF THE ILIAC VESSELS NOW BEING COMPROMISED, OR WEAKENED, THE PT NOW HAS PERMANENT ARTERIAL STENTS PLACED IN HER ILIAC VESSELS. TRADITIONAL REUSABLE GRASPING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312838 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening