BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 3603332 · Received January 23, 2014

    Report

    Report Number
    2183959-2013-01222
    Event Type
    Injury
    Date Received
    January 23, 2014
    Date of Event
    April 1, 2012
    Report Date
    December 29, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT. YASUTOMO SUZUKI, BONE-ANCHORED SLING CREATED WITH THE INVANCE SYSTEM FOR THE TREATMENT OF INCONTINENCE AFTER RADICAL PROSTATECTOMY: INITIAL EXPERIENCE IN JAPAN. JOURNAL OF NIPPON MEDICAL SCHOOL. APRIL 2012; 79 (2): 143-146.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2012-01222. IT WAS REPORTED VIA JOURNAL ARTICLE THE USE OF A BONE-ANCHORED SLING CREATED WITH THE INVANCE SYSTEM FOR THE TREATMENT OF URINARY INCONTINENCE AFTER RADICAL PROSTATECTOMY. THE PROCEDURE WAS PERFORMED WITH THE STRAIGHT-IN BONE-ANCHORING SYSTEM. THE PATIENT HAD USED 5 PADS/DAY FOR URINARY INCONTINENCE FOR THE 2 YEARS AFTER THE PROSTATECTOMY SURGERY. OPERATIVE TIME WAS 240 MINUTES, SCREWS WERE INSERTED WITHOUT EXPOSING THE PERIOSTEUM OF THE PUBIC BONES TO SUFFICIENT LIGHT, LEADING TO THE LOSS OF A SCREW AND A SUBSEQUENT INCREASE IN OPERATION TIME. IT WAS NOTED THAT THIS OPERATION DID NOT OTHERWISE REQUIRE GREAT MANUAL SKILL, AND TAKES APPROXIMATELY 1 HOUR. HOWEVER, THE AUTHOR INDICATED THAT CREATING THE BONE ANCHOR, WHICH IS NOT USED IN NORMAL URINARY ORGAN OPERATIONS, CAN BE DIFFICULT FOR SURGEONS WITHOUT EXPERIENCE WITH THE TECHNIQUE. BLOOD LOSS OF 10ML WAS RECORDED. POSTOPERATIVELY, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS WERE ADMINISTERED FOR PERINEAL PAIN, A COMPLICATION ASSOCIATED WITH THE BONE-ANCHORED SLING. NO URINARY INCONTINENCE WAS APPARENT AFTER REMOVAL OF THE FOLEY CATHETER, BUT MESH INFECTION DEVELOPED 1 WEEK POSTOPERATIVELY AND ANTIBIOTICS WERE ADMINISTERED. IT IS NOTED THAT MESH INFECTION APPEARS TO BE A RARE COMPLICATION AND NO CAUSE CAN BE IDENTIFIED, EXCEPT, PERHAPS FOR THE OPERATION TIME OF 4 HOURS. FURTHERMORE, THE AUTHOR NOTED, FISTULA CAUSED BY MESH INFECTION CAN BE DIFFICULT TO CLOSE AND MAY NECESSITATE MESH REMOVAL. THE MESH WAS REMOVED 3 MONTHS AFTER IMPLANTATION AND URINARY INCONTINENCE RETURNED TO PREOPERATIVE LEVELS. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54964 INVANCE MALE SLING SYSTEM SURGICAL MESH, POLYMERIC FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R