BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGRESS URETHRAL IMPLANT

    MDR report key: 2971823 · Received February 19, 2013

    Report

    Report Number
    1018233-2013-00437
    Event Type
    Injury
    Date Received
    February 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    LNM
    PMA / PMN Number
    P030030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESS POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS, THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: ¿THE TEGRESS URETHRAL IMPLANT CLINICAL TRIAL INVOLVED 374 TEGRESS IMPLANT TREATMENT INJECTIONS IN 174 SUBJECTS (MEAN FOLLOW-UP OF APPROX. 14 MONTHS). THERE WERE NO DEATHS AMONG STUDY PATIENTS. THE FOLLOWING TABLE LISTS THE TREATMENT RELATED ADVERSE EVENTS REPORTED DURING THE CLINICAL STUDY (INCIDENCE >2%). TREATMENT RELATED EVENTS ARE THOSE EVENTS THAT WERE DEEMED TO BE RELATED TO EITHER THE DEVICE OR THE PROCEDURE. ALL GENITOURINARY EVENTS WERE CLASSIFIED AS TREATMENT RELATED. NUMBER (%) SUBJECTS REPORTING TREATMENT RELATED ADVERSE EVENTS EVENT CATEGORY TEGRESS IMPLANT (N=174) URINARY TRACT INFECTION (UTI) 50 (29%) DELAYED VOIDING 32 (18%) DYSURIA 3 (18%) EXPOSED MATERIAL 28 (16%) URINARY URGENCY 24 (14%). URINARY FREQUENCY 22 (13%) GENITOURINARY (INFECTION TENDERNESS) 20 (11%) HEMATURIA 19 (11%) URGE INCONTINENCE 16 (9%) WORSENING OF INCONTINENCE (ONSET OF URGE) 14 (8%) OUTLET OBSTRUCTION 13 (7%). LEAKAGE OF URINE/STRESS INCONTINENCE 9 (5%) BULKING MATERIAL INJECTED INTO BLADDER 7 (4%) FATIGUE 3 (2%) ABNORMAL URINALYSIS 3 (2%) UTERINE FIBROIDS 3 (2%) OTHER 9>2%) 38 (N/A) OF THE TREATMENT RELATED ADVERSE EVENTS, 39% WERE CLASSIFIED AS MILD, 58% WERE CLASSIFIED AS MODERATE, AND 3% WERE CLASSIFIED AS SEVERE.¿ ¿THE SEVERE TREATMENT RELATED ADVERSE EVENTS INCLUDED: BLADDER SPASMS, BLADDER STONES, BULKING MATERIAL INJECTED INTO THE BLADDER, DELAYED VOIDING, EXPOSED BULKING MATERIAL, HEMATURIA, PELVIC PAIN, URGE INCONTINENCE, AND URINARY FREQUENCY. THE CLINICAL STUDY CONSISTED OF A PILOT OR FEASIBILITY PHASE (N=28), FOLLOWED BY THE EXPANDED STUDY PHASE (N=146). THERE WAS HIGHER OVERALL RATE OF GENITOURINARY ADVERSE EVENTS IN THE FEASIBILITY PHASE OF THE STUDY THAN IN THE EXPANDED PHASE. IN PARTICULAR, THE RATE OF ¿EXPOSED MATERIAL¿ WAS HIGHER (32% VS. 13%). THIS REDUCTION IN THE RATE OF EXPOSED MATERIAL WAS ACHIEVED AS A RESULT OF MODIFICATIONS TO THE TEGRESS IMPLANT INJECTION INSTRUCTIONS AND INVESTIGATOR TRAINING. DURING THE COURSE OF THE CLINICAL INVESTIGATION (BOTH STUDY PHASES), 28 SUBJECTS (16%) RECEIVING TEGRESS URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. PATIENTS EXPERIENCING EXPOSED MATERIAL OFTEN REPORTED OTHER EVENTS, PARTICULARLY DYSURIA, DELAYED VOIDING, URINARY TRACT INFECTION, HEMATURIA, URINARY FREQUENCY, AND URINARY URGENCY. EXPOSED TEGRESS IMPLANT MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION TOO PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. THE PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OR FORCEPS TO FACILITATE HEALING. THE MAJORITY OF PATIENTS WERE INJECTED VIA THE TRANSURETHRAL APPROACH, WHILE A SMALL PROPORTION OF PATIENTS WERE INJECTED PERIURETHRALLY; AS A RESULT, THE TEGRESS URETHRAL IMPLANT INSTRUCTIONS FOR USE ARE LIMITED TO TRANSURETHRAL ADMINISTRATION. POTENTIAL ADVERSE EVENTS ALTHOUGH NOT REPORTED IN THE CLINICAL STUDY, OTHER POTENTIAL ADVERSE EVENTS WHICH MAY OCCUR INCLUDE EROSION, ERYTHEMA, EMBOLIC PHENOMENA, AND VASCULAR OCCLUSION.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED IN 2005, A MASS WAS FOUND IN 2011 WHICH HER DOCTORS THOUGHT COULD BE BLADDER CANCER. THE DOCTORS REMOVED MOST OF THE DETERIORATING IMPLANT WHICH WAS WRAPPED AROUND THE PATIENT¿S URETHRA. THE IMPLANT COULD NOT BE FULLY REMOVED AND THE PATIENT WAS REFERRED TO A SPECIALIST FOR THE REMOVAL OF THE REMAINDER OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72540 TEGRESS URETHRAL IMPLANT LNM C.R. BARD, INC. (COVINGTON) NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention