BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    MDR report key: 10506857 · Received September 9, 2020

    Report

    Report Number
    3005580113-2020-00410
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    June 13, 2019
    Report Date
    September 9, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: FAD STENT, URETERAL.

    Description of Event or Problem · 1

    ACCORDING TO THE JOURNAL ARTICLE: "NAVETTA, 2019 ¿TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION¿ COMPLAINT #3. NUMBER OF DEVICES: 2. BRIEF DESCRIPTION: NAVETTA 2019 - ¿FLANK PAIN." DESCRIPTION OF EVENT: FLANK PAIN. PATIENT OUTCOME: PATIENT REQUIRED NEPHROSTOMY. AS PER TABLE 1 - PATIENT # 4 TRS FAILED DUE TO FLANK PAIN AND RENAL FAILURE AND WAS MANAGED BY A NEPHROSTOMY. AS PER LITERATURE PAPER; ''IN OUR STUDY, ONLY ONE PATIENT WITH METASTATIC COLON CANCER WAS NEVER SUCCESSFULLY MANAGED WITH TRS. A PCN WAS REPLACED AFTER JUST 6 DAYS FOR FLANK PAIN, AND HE DIED 82 DAYS LATER.'' MEDICAL ADVISOR HAS CONFIRMED THAT DEATH IS LIKELY RELATED TO DISEASE / PALLIATION AND NOT CAUSED / CONTRIBUTED BY DEVICE' PLEASE NOTE: THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN 1 RENAL UNITS FOR PATIENT #4 THAT EQUATES TO A TOTAL OF 2 RMS STENTS BEING PLACED. PLEASE ALSO NOTE, ALTHOUGH WE CANNOT CONFIRM THE EXACT RPN OF THE RESONANCE METALLIC DOUBLE-J URETERAL STENTS USED IT HAD THE POTENTIAL TO BE ANYONE IF THE FOLLOWING: RMS-060012-R, RMS-060014-R, RMS-060016-R, RMS-060018-R, RMS-060020-R, RMS-060022-R, RMS-060024-R, RMS-060026-R, RMS-060028-R, RMS-060030-R. THIS FILE IS CREATED TO CAPTURE FLANK PAIN AND RENAL FAILURE REQUIRING NEPHROSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976485 RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention