BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESONANCE STENT SET

    MDR report key: 2549106 · Received April 23, 2012

    Report

    Report Number
    3001845648-2012-00020
    Event Type
    Death
    Date Received
    April 23, 2012
    Report Date
    March 27, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED CONFIRMED THE DEVICE WAS A RESONANCE METALLIC STENT, HOWEVER, THE ACTUAL RPN AND LOT NUMBER OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED, THEREFORE, IT WAS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL; THEREFORE, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE PART # AND LOT # OF THE DEVICE IS UNK; THEREFORE, IT IS NOT POSSIBLE TO REVIEW THE MFG RECORDS OR TO CONDUCT A SAMPLE TEST. RESONANCE DEVICES ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PTS WITH EXTRINSIC URETERAL OBSTRUCTION. IT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE THAT "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE". A CAUTION IN THE INSTRUCTIONS FOR USE INDICATE THAT "COMPLICATIONS OF URETERAL STENT PLACEMENT ARE DOCUMENTED. USE OF THIS DEVICE SHOULD BE BASED UPON CONSIDERATION OF RISK-BENEFIT FACTORS AS THEY APPLY TO YOUR PT. INFORMED CONSENT SHOULD BE OBTAINED TO MAXIMIZE PT COMPLIANCE WITH F/U PROCEDURES". THE INSTRUCTIONS FOR USE INDICATE THAT "PTS SHOULD BE CHECKED AT REGULAR INTERVALS UTILIZING TECHNIQUES SUCH AS ABDOMINAL X-RAY (KUB FILM). PTS USING CALCIUM SUPPLEMENTS MUST BE MORE CLOSELY MONITORED FOR POSSIBLE STENT ENCRUSTATION. THE STENT MUST BE REMOVED IF ENCRUSTATION HAMPERS DRAINAGE." NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME, HOWEVER, CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR EMERGING COMPLAINT TRENDS.

    Description of Event or Problem · 1

    PHYSICIAN NOTED THAT PT HAD AN ARTERIO URETERAL FISTULA AND ONCE RESONANCE STENT REMOVED, BLEEDING WAS UNABLE TO STOP AND PT DIED. DOESN'T KNOW IF IT WAS THE STENT OR NOT, BUT FEELS THE FISTULA WAS CREATED BY THE METAL STENT. BELIEVED THAT THE METAL STENT UNDER EXTRINSIC COMPRESSION CAUSED ARTERIO URETERAL FISTULA. ATTEMPT TO STOP THE BLEEDING OF THE ARTERIO URETERAL FISTULA. ADDITIONAL INFO RECEIVED (B)(4) 2012 - STENT REMOVED AT (B)(6) HOSP. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESONANCE STENT SET NONE FAD COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death