BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD TEGRESS URETHRAL BULKING AGENT

    MDR report key: 802326 · Received December 27, 2006

    Report

    Report Number
    1018233-2006-00227
    Event Type
    Injury
    Date Received
    December 27, 2006
    Date of Event
    November 6, 2006
    Report Date
    December 27, 2006
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE FORMS A COHESIVE, SPONGY MASS THAT SERVES TO BULK SURROUNDING TISSUE AND IS NOT SUBJECT TO ABSORPTION OR ENZYMATIC BREAKDOWN WITHIN THE BODY. THE LOW VISCOSITY OF THE IMPLANT SOLUTION AND THE COHESIVE MASS OF THE RESULTING IMPLANT REQUIRE SPECIFIC ATTENTION TO THE INJECTION SITE, NEEDLE ORIENTATION, DEPTH OF NEEDLE PLACEMENT, RATE OF INJECTION, AND INJECTION VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. DURING THE COURSE OF THE CLINICAL INVESTIGATION, 28 SUBJECTS RECEIVING THE URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. A PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OR FORCEPS TO FACILITATE HEALING. THE IFU INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. CONTRAINDICATIONS INCLUDE PTS WITH THE FOLLOWING CONDITIONS: ACUTE CYSTITIS, URETHRITIS, OTHER ACUTE OR CHRONIC GENITOURINARY TRACT INFECTIONS, OR FRAGILE URETHRAL MUCOSAL LINING. BASELINE REPORT PREVIOUSLY PROVIDED. TO FACILITATE ROOT CAUSE ANALYSIS OF EXPOSED IMPLANT MATERIAL, BARD CREATED A CAUSE AND EFFECT DIAGRAM. IN THIS DIAGRAM, WE ANALYZED IMPACT OF ACCESSORIES, IMPLANT MATERIAL, PT SPECIFIC FACTORS AND INJECTION TECHNIQUE FACTORS. BARD CONDUCTED A RETROSPECTIVE REVIEW OF GENYX AND BARD DMRS. AS SUBMITTED IN THE PMA SUPPLEMENT #P030030/S002 FOR A FACILITIES CHANGE, BOTH DMRS ARE EQUIVALENT IN ALL RELEVANT ASPECTS INCLUDING: MATERIALS, QUANTITIES OF DMSO AND EVOH, MIXING TIME AND TEMPERATURE; THE PROCESSES FOR MIXING, TRANSFER, FILLING, SEALING THE VIAL, CAPPING AND LABELING OPERATIONS; AND IN PROCESS AND FINAL TEST AND INSPECTION REQUIREMENTS. A REVIEW OF BARD DHRS FROM JUNE 2005 TO JULY 2006 FOUND THAT 1) ALL RAW MATERIALS WERE FOUND TO BE WITHIN SPECIFICATION AND 2) ALL 14 LOTS WERE MANUFACTURED USING THE SAME PROCEDURES, METHODS, INSPECTIONS AND SPECIFICATIONS AS APPROVED IN THE PMA. THE MFG PARAMETERS RELATED TO QUANTITY OF DMSO AND EVOH, MIXING TIME AND TEMPERATURE WERE WITHIN THE ACCEPTABLE RANGES. THE REVIEW VERIFIED THAT EACH LOT PRODUCED WAS MANUFACTURED IN ACCORDANCE WITH THE DMR. BASED ON OUR DHR REVIEW, NO CHANGES WERE NOTED, AND THEREFORE, THE IMPLANT MATERIAL AND IMPACT OF ACCESSORIES HAVE BEEN ELIMINATED AS A ROOT CAUSE. BASED ON THIS PROCESS OF ELIMINATION, PT SELECTION AND INJECTION TECHNIQUE WERE IDENTIFIED AS THE MOST LIKELY ROOT CAUSES FOR THE EXPOSED IMPLANT MATERIAL REPORT. BARD'S ROOT CAUSE ANALYSIS IDENTIFIES PT SELECTION AND INJECTION TECHNIQUE AS POTENTIAL CONTRIBUTING FACTORS TO SUCCESSFUL PT OUTCOMES. BARD PERFORMED A REVIEW OF ADVERSE EVENTS REPORTED FOR EXPOSED MATERIAL, EROSION AND NECROSIS ON A PER PHYSICIAN BASIS. THE ANALYSIS SHOWED THAT THE EVENTS WERE REPORTED ACROSS MULTIPLE PHYSICIANS WITH FEW OCCURRENCES (=<2). BARD HAS CONSULTED WITH AN EXPERT IN UROGYNECOLOGY REGARDING HIS CLINICAL EXPERIENCE WITH TEGRESS. HE PROVIDED A CLINICAL EXPERT REVIEW OF THE SEVERITY OF ADVERSE EVENTS AND THE IMPORTANCE OF PROPER PT SELECTION AND INJECTION TECHNIQUE TO REDUCE ADVERSE EVENT REPORTS. THE CLINICAL EXPERT OPINION CONFIRMED OUR CONCLUSION THAT PROPER PT SELECTION AND INJECTION TECHNIQUE ARE CONTRIBUTORS TO EXPOSED MATERIAL. BARD'S EXISTING PHYSICIAN TRAINING PROGRAM AND THE IFU FOCUSES ON PROPER PT SELECTION AND INJECTION TECHNIQUE. CONSISTENT WITH THE IFU, BARD HAS EMPHASIZED THESE CRITICAL FACTORS BY SENDING ALL USERS TIP SHEETS AND A DIRECT MAILER FROM A KEY MEDICAL OPINION LEADER.

    Description of Event or Problem · 1

    THIS MDR IS BEING FILED AS EXPOSED IMPLANT MATERIAL. IT WAS REPORTED THAT DURING A RE-TREATMENT WITH A URETHRAL BULKING IMPLANT, EXPOSED MATERIAL WAS NOTED IN THE URETHRA FROM THE INITIAL INJECTION. THE EXPOSED IMPLANT MATERIAL WAS REMOVED THROUGH THE CYSTOSCOPE AND THE SECOND INJECTION WAS NOT PERFORMED. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD TEGRESS URETHRAL BULKING AGENT URETHRAL BULKING AGENT LNM C.R. BARD, INC. NA 43DQH003

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention