BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    MDR report key: 10507271 · Received September 9, 2020

    Report

    Report Number
    3005580113-2020-00411
    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
    Product Problem
    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¿. "WE REPORT OUR EXPERIENCE PLACING TANDEM RESONANCE STENTS (TRS) IN A SINGLE URETER OF PATIENTS WHO FAILED MANAGEMENT WITH A SINGLE RESONANCE STENT. WE REPORT OUR EXPERIENCE IN A SMALL SERIES OF PATIENTS WHOSE URETERAL OBSTRUCTION WAS MANAGED IN THIS FASHION DUE TO FAILURE OF A SINGLE RESONANCE STENT AND DECLINED PLACEMENT OF A PCN." "HYDRONEPHROSIS ON FOLLOW-UP IMAGING AND RENAL FAILURE WERE THE MOST COMMON REASONS FOR FAILURE OF A SINGLE RESONANCE STENT, WITH RATES OF 100% AND 71.4%, RESPECTIVELY 4 PATIENTS WITH A MEDIAN AGE OF 62 YEARS WERE MANAGED WITH TRS." 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. AS CONFIRMED BY CLINICAL ADVISOR, RENAL FAILURE WAS A CASCADING EFFECT OF THE HYDRONEPHROSIS AND BOTH ADVERSE EVENTS ARE RELATED. THIS FILE IS CREATED TO CAPTURE 4 CASES OF HYDROPNEPHROSIS AND RENAL FAILURE DUE TO FAILURE OF SINGLE RMS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972866 RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention