BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 3239867 · Received July 19, 2013

    Report

    Report Number
    3001845648-2013-00065
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO (B)(4) (RMS) STENT SETS OF LOT NUMBER C856695 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: "WHEN THEY ATTEMPTED TO REMOVE THE RESONANCE STENT ON THE LEFT SIDE THEY FOUND THE END OF THE STENT CURL LODGED IN THE BLADDER WALL. AFTER PULLING AND ATTEMPTING TO MOVE THE STENT COIL WITH THE REUSABLE GRASPER FOR A FEW MINUTES THEY WERE ABLE TO GET A GOOD ANGLE TO GENTLY PULL THE END OF THE STENT FREE FROM THE BLADDER TISSUE AND THE STENT WAS REMOVED WITH NO BLEEDING OR APPARENT INJURY TO THE PATIENT." ON EVALUATION OF THE RETURNED RESONANCE DEVICE BY THE RELEVANT ENGINEER, THE STENT WAS NOTED TO BE THE CORRECT SHAPE. NO KINKS WERE VISIBLE ON THE STENT. THERE WAS MINOR SIGNS OF ENCRUSTATION AND DISCOLORATION ON THE STENT. THERE WAS NO EVIDENCE OF TISSUE INGROWTH ON THE RETURNED STENT, AND NO ISSUES THAT COULD HAVE CAUSED THE STENT NOT TO FUNCTION AS INTENDED WERE NOTED. TWO IMAGES WERE PROVIDED SHOWING THE STENT CURL LODGED IN THE BLADDER WALL. BASED ON THE IMAGES PROVIDED, THE CUSTOMER COMPLAINT COULD BE CONFIRMED. A DEFINITIVE CAUSE FOR THE CUSTOMER'S COMPLAINT WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK (B)(4) COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE. WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS INDICATED KIDNEY FAILURE. A CAUTION IN THE INSTRUCTIONS FOR USE, IFU0020-12, ADVISES THE FOLLOWING: "PATIENTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PATIENTS USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE." AS PER THE IFU, REMOVAL OR REPLACEMENT OF A RESONANCE STENT IS STANDARD PROCEDURE. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER C856695 REVEALED NO DISCREPANCIES THAT COULD HAVE CAUSED THE COMPLAINT ISSUE. THE RMS-(B)(4) DEVICES ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. THESE DEVICES ARE INTENDED FOR ONE-TIME USE. AS PER INSTRUCTIONS FOR USE FOR THE RESONANCE METALLIC URETERAL STENT SET, 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 PATIENT. INFORMED CONSENT SHOULD BE OBTAINED TO MAXIMIZE PATIENT COMPLIANCE WITH FOLLOW-UP PROCEDURES." A FINAL CAUTION INDICATES THAT: "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE." THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS COMPLAINT REPRESENTS AN ISOLATED OCCURRENCE FOR THIS RPN. QUALITY ENGINEERING ASSESSED THE COMPLAINT USING THE HEALTH RISK ASSESSMENT (HRA) SCALE FOR SEVERITY, OCCURRENCE AND PROBABILITY OF INJURY AND THE RISK HAS BEEN DETERMINED TO BE LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS REQUIRED. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS COMPLAINT REPRESENTS AN ISOLATED OCCURRENCE FOR THIS RPN. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE RESONANCE STENT ON THE RIGHT SIDE WAS REMOVED AND REPLACED WITH A 6X22 RESONANCE WITH NO ISSUES. WHEN THEY ATTEMPTED TO REMOVE THE RESONANCE STENT ON THE LEFT SIDE THEY FOUND THE END OF THE STENT CURL LODGED IN THE BLADDER WALL. THE UO IS ON THE LEFT SIDE, AND THE CURL IS ON THE RIGHT HAND SIDE. AFTER PULLING AND ATTEMPTING TO MOVE THE STENT COIL WITH THE REUSABLE GRASPER FOR A FEW MINUTES THEY WERE ABLE TO GET A GOOD ANGLE TO GENTLY PULL THE END OF THE STENT FREE FROM THE BLADDER TISSUE AND THE STENT WAS REMOVED WITH NO BLEEDING OR APPARENT INJURY TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DR. (B)(6) DESCRIBED THIS AS THE SAME ISSUE THEY HAD WITH THE RIGHT URETER IN (B)(6), ONLY NOW WITH THE BLADDER INSTEAD OF THE KIDNEY AND ON THE OTHER SIDE. I ASKED WHAT HE FELT COULD HAVE CAUSED THIS AND HE SAID HE DID NOT KNOW. THE STENTS WERE ONLY IN FOR 4 MONTHS AND THE BLADDER IS HEALTH (NO RADIATION, STRUCTURING AT THE UO, ETC). SINCE THIS WAS THE SECOND TIME HE FELT TISSUE HAD GROWN INTO THE RESONANCE STENT, HE DECIDED TO PLACE A STANDARD 6X22 UNIVERSA FIRM IN THE LEFT URETER. NOTE: THE ISSUE REFERRED TO ABOVE IN (B)(6) WAS IN RELATION TO TISSUE INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337774 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD C856695

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other