BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    MDR report key: 10506859 · Received September 9, 2020

    Report

    Report Number
    3005580113-2020-00409
    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

    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 #2 NUMBER OF DEVICES: 4 BRIEF DESCRIPTION: NAVETTA 2019 - ¿RENAL FAILURE ¿ DESCRIPTION OF EVENT: ALL PATIENTS IN STUDY HAD A SINGLE RMS FAIL PRIOR TO THE STUDY. RENAL FAILURE 71.4% WITH ONE RESONANCE STENT. 2 PATIENTS SUFFERED RENAL FAILURE AFTER TRS PATIENT OUTCOME: REQUIRED NEPHROSTOMY 59 DAYS AFTER TRS. AS PER TABLE 1 IN PAPER - PATIENT #2 TRS FAILED DUE TO HYDRONEPHROSIS AND RENAL FAILURE WHICH WAS MANAGED WITH A NEPHROSTOMY. AS PER LITERATURE PAPER; '' THE OTHER PATIENT WITH MUO DUE TO METASTATIC COLON CANCER FAILED DUE TO STENT OBSTRUCTION AND RENAL FAILURE. STILL,SHE WAS MANAGED WITH TRS FOR 59 DAYS AND DIED 277 DAYS AFTER TRS FAILURE.'' MEDICAL ADVISOR HAS CONFIRMED THAT RMS DEVICE DID NOT CAUSE / CONTRIBUTE TO THE DEATH WHICH OCCURRED 277 DAYS AFTER TRS FAILURE AND DEATH WAS LIKELY RELATED TO DISEASE / PALLIATION.' 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 2 RENAL UNITS FOR THIS PARTICULAR PATIENT THAT EQUATES TO A TOTAL OF 4 RMS STENTS BEING PLACED IN THIS CASE 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 STENT OBSTRUCTION WHICH LEAD TO HYDRONEPHROSIS AND RENAL FAILURE IN PATIENT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976487 RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention