BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6000037-1999-00023

    MDR report key: 256764 · Received December 29, 1999

    Report

    Report Number
    6000037-1999-00023
    Event Type
    Injury
    Date Received
    December 29, 1999
    Date of Event
    November 26, 1999
    Report Date
    November 29, 1999
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL SEGMENT OF THE STENT BROKE AND DETACHED IN THE PT'S KIDNEY FOLLOWING URETERAL STENT PLACEMENT IN A PT WITH CERVIX CARCINOMA. PERCUTANEOUS RETRIEVAL OF THE DETACHED STENT SEGMENT WAS SUCCESSFUL. FOLLOW-UP INDICATED THAT DIFFICULTIES MAY HAVE BEEN ENCOUNTERED DURING DEPLOYMENT OF THE STENT. THE REMAINING PORTION OF THE STENT REMAINS IMPLANTED AND IS DRAINING WELL. THE PT'S CONDITION IS SATISFACTORY. THE DEVICE IS CURRENTLY BEING EVALUATED BY THIS MFR. FOLLOWING COMPLETION OF THE ENGINEERING EVAL, A SUPPLEMENT WILL BE FORWARDED UNDER 600037-1999-00023. SINCE CO'S FOLLOW UP INDICATED THAT RESISTANCE MAY HAVE BEEN ENCOUNTERED DURING STENT DEPLOYMENT AND THE PT WAS CRITICALLY OBESE, CO BELIEVES THAT PT'S ANATOMY AND/OR USER TECHNIQUE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO IS UNABLE TO DETERMINE THE EXACT CAUSE OF THIS EVENT AT THIS TIME.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention