BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 17884836 · Received October 6, 2023

    Report

    Report Number
    3005580113-2023-00114
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    July 26, 2023
    Report Date
    July 31, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K063742. DEVICE EVALUATION: THE RESONANCE STENT SET DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS RAISED FROM THE LITERATURE ARTICLE BHATT ET AL,2022 ¿EVALUATION OF RENAL FUNCTION AND STENT DURABILITY FOLLOWING RESONANCE STENT PLACEMENT FOR BENIGN DISEASE.¿ AND WILL CAPTURE THE CASES OF THE USER ERROR OF THE STENT INDWELLING LONGER THAN 12 MONTHS. THIS COMPLAINT IS RELATED TO (B)(4) WHICH WILL CAPTURE THE OFF-LABEL USE OF THE STENT. LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, PRIOR TO DISTRIBUTION ALL RESONANCE STENT SET DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. ((B)(4)]). REVIEW OF HISTORICAL DATA IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, IFU0020, STATES THE FOLLOWING: ¿THE STENT MUST NOT REMAIN INDWELLING MORE THAN 12 MONTHS.¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE IDENTIFIED. FROM CUSTOMERS TESTIMONY IT IS KNOWN THE RESONANCE STENT DEVICE WAS INDWELLING GREATER THAN 12 MONTHS. AS STATED IN THE IFU THE STENT MUST NOT REMAIN INDWELLING MORE THAN 12 MONTHS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. USER/USE ERROR COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/ CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER THE DEVICES WERE LEFT INDWELLING GREATER THAN 12 MONTHS. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE IDENTIFIED. FROM CUSTOMERS TESTIMONY IT IS KNOWN THE RESONANCE STENT DEVICE WAS INDWELLING GREATER THAN 12 MONTHS. AS STATED IN THE IFU THE STENT MUST NOT REMAIN INDWELLING MORE THAN 12 MONTHS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. USER/USE ERROR COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS REQUIRED SURGICAL INTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL "FOLLOW UP" #1 REPORT WAS INADVERTENTLY SUBMITTED UNDER THE INCORRECT MANUFACTURER/IMPORTER NAME COOK MEDICAL LLC BY COOK IRELAND LTD. THEREFORE, COOK MEDICAL LLC IS REQUESTING THAT THIS SUPPLEMENTAL FOLLOW UP #1 AND # 2 3005580113-2023-00114 MDR BE CANCELED.

    Description of Event or Problem · 0

    (B)(6), 2022 ¿ EVALUATION OF RENAL FUNCTION AND STENT DURABILITY FOLLOWING RESONANCE STENT PLACEMENT FOR BENIGN DISEASE. RESONANCE STENT PLACEMENT - THE ETIOLOGY OF BENIGN URETERAL OBSTRUCTION (BUO) WAS ANALYZED BETWEEN THE 2 SUBGROUPS. IN SUBGROUP A, IATROGENIC URETERAL STRICTURE WAS THE MOST COMMON ETIOLOGY. THIS DEVELOPED MOST AFTER ENDOSCOPIC SURGERY (34.4%), FOLLOWED BY ABDOMINOPELVIC SURGERY (9.4%) AND RADIATION THERAPY (6.3%). THE REST OF THE URETERAL STRICTURES IN SUBGROUP A WERE ASSOCIATED WITH EXTRINSIC COMPRESSION (9.37%), CONGENITAL OBSTRUCTION (3.12%), AND TRAUMA (3.12%). IN ONE-THIRD OF THE PATIENTS (34.3%) IN SUBGROUP A, NO SPECIFIC CAUSE FOR THE STRICTURE WAS PROVIDED OR IDENTIFIABLE. IN SUBGROUP B, RADIATION-INDUCED URETERAL STRICTURE (36.4%) WAS THE MOST COMMON ETIOLOGY, FOLLOWED BY IDIOPATHIC URETERAL STRICTURE (27.3%), CONGENITAL URETERAL STRICTURE (18.2%) AND EXTRINSIC COMPRESSION (18.2%). THIS COMPLAINT WAS OPENED TO CAPTURE 2 CASES OF USER ERROR OF A RESONANCE STENT DEVICE - INDWELLING TIME > 12 MONTHS ON 2 OUT OF 38 PATIENTS. REQUIRED INTERVENTION/ADDITIONAL PROCEDURES. SEVERITY OF 4. TOTAL BETWEEN (B)(4) 43 PATIENTS, 62.7 +/- 14.2 YEARS, FEMALE 23, MALE 20, BMI (KG/M2) 28.0 ± 6.8, WHITE 29, ASIAN 8, OTHER 6.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 31-JUL-2024.

    Description of Event or Problem · 0

    PLEASE SEE H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307047 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention