BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 21807695 · Received April 9, 2025

    Report

    Report Number
    3001845648-2025-00175
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    January 4, 2021
    Report Date
    June 11, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS FILE WAS CREATED IN RESPONSE TO THE ATTACHED PMCF STUDY AND RELATES TO STENT MIGRATION OF AN RMS-060024-R DEVICE. THROUGH THE INVESTIGATION IT WAS CLARIFIED THAT THE INDEX PROCEDURE OCCURRED ON (B)(6) 2020 AND RMS-060024-R WAS PLACED WITHIN THE RIGHT URETER. THIS DEVICE WAS REMOVED (B)(6) 2021 DUE TO THE STENT MIGRATION AND REPLACED WITH RMS-060026-R. THIS DEVICE WAS THEN REPLACED ON (B)(6) 2021. THERE WERE NO DEVICE DEFICIENCIES RELATED TO THIS SECOND DEVICE. AS THERE WAS NO EVIDENCE FROM THE INFORMATION TO DATE OF ANY DEVICE MALFUNCTION OR ADVERSE EFFECT ASSOCIATED WITH THE REPLACEMENT OF THE 2ND DEVICE NO ADDITIONAL COMPLAINT WAS OPENED. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL. AS PER THE INSTRUCTIONS FOR USE, IFU0020 WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE: ALLERGIC REACTION TO NICKEL, BLADDER SPASM, DIMINISHED URINE DRAINAGE/STENT OCCLUSION, FEVER, FISTULA FORMATION INCLUDING ARTERIOURETERAL FISTULA, HEMORRHAGE, HYDRONEPHROSIS, INFECTION, INSUFFICIENT URINE DRAINAGE, LOSS OF RENAL FUNCTION, PAIN/DISCOMFORT, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND/OR BLADDER, PERITONITIS, PYURIA, STENT DEGRADATION/FRACTURE, STENT DISLODGEMENT/MIGRATION, STENT ENCRUSTATION, STENT FAILURE, TISSUE INGROWTH, URETERAL REFLUX, URINARY SYMPTOMS (FREQUENCY, URGENCY, INCONTINENCE, DYSURIA, HEMATURIA), URINARY TRACT TISSUE EROSION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE LISTS STENT DISLODGEMENT/MIGRATION AS A POTENTIAL ADVERSE EVENT THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT. THERE IS NO EVIDENCE TO SUGGEST THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0020). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO INHERENT RISK OF THE DEVICE, AS MIGRATION OR STENT DISLODGEMENT IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE RMS DEVICE. AS THE COMPLAINT STENT WAS REPLACED WITH A LONGER ONE IT IS ALSO POSSIBLE THAT THE STENT SELECTED MAY NOT HAVE BEEN THE CORRECT LENGTH WHICH COULD HAVE LED TO THE MIGRATION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO PAGE 5 OF THE PMCF STUDY REPORT NO ADVERSE EVENTS INVOLVING THE STUDY DEVICE WAS DOCUMENTED. THIS STENT WAS REMOVED 05FEB2021 DUE TO THE STENT MIGRATION AND REPLACED WITH A STENT FROM A RMS-060026-R DEVICE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENT.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: ON (B)(6) 2020 A CYSTOSCOPY WITH SUCCESSFUL STENT PLACEMENT WAS DONE DUE TO RIGHT URETERAL OBSTRUCTION. THE STENT WAS PLACED IN THE RIGHT URETER WITH RETROGRADE ACCESS. AFTER THE INDEX PROCEDURE THE PATIENT DEVELOPED ACUTE KIDNEY INJURY AND ON (B)(6) 2021 (131 DAYS POST PROCEDURE) A CYSTOSCOPY WAS PERFORMED WHICH SHOWED THE STENT HAD DISTALLY MIGRATED. ON (B)(6) 2021 (163 DAYS POST PROCEDURE) THE STENT WAS REPLACED WITH A LONGER ONE (RMS-060026-R).

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-JUN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454380 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD G34110

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female Required Intervention