BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 17720883 · Received September 11, 2023

    Report

    Report Number
    3005099803-2023-04836
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    June 22, 2022
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729772880
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6), 2022, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE REVISION SURGERY. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: (B)(6). BLOCK H6: IMDRF PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF EROSION OF BLADDER SUSPENSION MESH. IMDRF PATIENT CODE E230901 CAPTURES THE REPORTABLE EVENT OF CALCIFIED SLING. IMDRF PATIENT CODE E230901 CAPTURES THE REPORTABLE EVENT OF BLADDER STONE. IMDRF IMPACT CODES F1905 CAPTURE THE REPORTABLE EVENTS OF EXCISION OF MESH CALCIFICATION AND ASSOCIATED BLADDER STONE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED DURING AN EXAMINATION UNDER ANESTHESIA AND A TENSION-FREE VAGINAL TAPE PROCEDURE USING AN ADVANTAGE KIT WITH CYSTOSCOPIC GUIDANCE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2018, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PATIENT HAD A HISTORY OF STRESS URINARY INCONTINENCE FOLLOWING A RETROPUBIC MID-URETHRAL SLING PLACEMENT IN 2017 AND WAS COMPLICATED BY MESH EROSION AT THE LEVEL OF THE BLADDER NECK AND NEAR THE URETHRAL ORIFICES. ON (B)(6), 2022, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, TRANSVESICAL EXCISION OF INTRAVESICAL PORTION OF ERODED MID-URETHRAL MESH, EXCISION OF MESH CALCIFICATION AND ASSOCIATED BLADDER STONE, BILATERAL 5F URETERAL CATHETER PLACEMENT AND REMOVAL AND FOLEY CATHETER PLACEMENT (18F LATEX). THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097993 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 0021762753 08714729772880

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention