BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 19410843 · Received May 28, 2024

    Report

    Report Number
    2124215-2024-32111
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE EXACT AGE OF THE PATIENTS ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENTS WERE OVER 18 YEARS. BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2024, PUBLICATION DATE, AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: THE OBTRYX AND SOLYX DEVICES WERE IMPLANTED AT UNIVERSITY OF CAMPINAS AND THE JUNDIAI MEDICAL SCHOOL BY THE FOLLOWING SURGEONS: EDILSON BENEDITO DE CASTRO LUIZ GUSTAVO OLIVEIRA BRITO ANA CAROLINA MARCHESINI CAMARGO BLOCK G2: LITERATURE: LISBOA, R.B.B., FABER, M.D.A., PEREIRA, G.M.V., DE CASTRO, E.B., CAMARGO, A.C.M., JULIATO, C.R.T., & BRITO, L.G.O. (2024). TRANSOBTURATOR VERSUS MINISLING FOR URINARY INCONTINENCE: A RANDOMIZED CONTROLLED TRIAL. UROGYNECOLOGY, 3, 443-451. HTTPS://DOI.ORG/10.25824/REDU/ENWDWB BLOCK H6: IMDRF PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF MESH EROSION. IMPACT CODES F1905: DEVICE REVISION OR REPLACEMENT AND F1202: DISABILITY CAPTURE THE REPORTABLE EVENTS OF LOCAL EXCISION OF THE MESH AND PHYSICAL LIMITATIONS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN OBTRYX SYSTEM AND A SOLYX SINGLE INCISION SLING (SIS) SYSTEM THROUGH THE ARTICLE TRANSOBTURATOR VERSUS MINISLING FOR URINARY INCONTINENCE: A RANDOMIZED CONTROLLED TRIAL, BY RODRIGO BARTILLOTI BARACHISIO LISBOA, MD, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2018 AND MARCH 2020, A GROUP OF PATIENTS WERE INVITED TO PARTICIPATE IN A STUDY AND WERE FOLLOWED UP AT 6 AND 12 MONTHS AFTER THEIR SURGERY. 58 PATIENTS UNDERWENT A MIDURETHRAL TRANSOBTURATOR (TOT) SLING PROCEDURE AND 56 UNDERWENT AN SIS PROCEDURE FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE OBJECTIVE OF THE RESEARCH WAS TO EVALUATE THE PROGRESS OF THE PATIENTS USING TWO QUESTIONNAIRES: THE KINGS OF HEALTH QUESTIONNAIRE (KHQ), WHICH CONSISTED OF QUESTIONS DIVIDED INTO EIGHT DOMAINS OF QUALITY OF LIFE (GENERAL HEALTH PERCEPTION, INCONTINENCE IMPACT, ROLE LIMITATIONS, PHYSICAL LIMITATIONS, SOCIAL LIMITATIONS, PERSONAL RELATIONSHIPS, EMOTIONS, AND SLEEP/ENERGY); AND THE PATIENT GLOBAL IMPRESSION OF IMPROVEMENT (PGI-I), WHICH HAD ONLY ONE QUESTION THAT MEASURED THE PATIENT'S IMPRESSION OF CHANGE AFTER A GIVEN EVENT INTO A NUMBER, RATED FROM MUCH BETTER TO MUCH WORSE. COMPARING THE SIS GROUP TO THE TOT GROUP, THE SIS GROUP HAD A SMALLER BLOOD LOSS (15-ML DIFFERENCE) AND A SHORTER SURGICAL TIME. HOWEVER, AFTER 6 AND 12 MONTHS OF TREATMENT, THE TOT GROUP PRESENTED BETTER RESULTS THAN THE SIS GROUP, AND BETTER SUBJECTIVE CURE RATES COMPARED WITH THE SIS. MESH EROSION WAS OBSERVED IN 7 CASES IN THE SIS GROUP, WHILE NO CASES WERE REPORTED IN THE TOT GROUP. OF THESE CASES, 6 WERE TREATED WITH TOPICAL ESTROGEN, AND 1 REQUIRED A LOCAL EXCISION IN THE OUTPATIENT CLINIC WITH LOCAL ANESTHESIA. ADDITIONALLY, 8 PATIENTS FROM THE SIS GROUP REQUIRED REOPERATION DUE TO STRESS URINARY INCONTINENCE (SUI) RELAPSE, WHILE ONLY 3 PATIENTS FROM THE TOT GROUP HAD TO UNDERGO A REOPERATION FOR THE SAME REASON. FURTHERMORE, THE PATIENTS IN THE SIS GROUP HAD HIGHER KHQ SCORES, WHICH NEGATIVELY AFFECTED THEIR QUALITY OF LIFE IN TERMS OF ROLE LIMITATIONS AND PHYSICAL LIMITATIONS AFTER SIX MONTHS. EVEN AFTER 12 MONTHS, THE SIS GROUP CONTINUED TO HAVE WORSE SCORES IN TERMS OF INCONTINENCE IMPACT, PHYSICAL LIMITATIONS, AND SEVERITY MEASURES. HOWEVER, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS IN TERMS OF GENERAL RELATIONSHIPS, EMOTIONS, AND SLEEP/ENERGY DOMAINS. ON THE OTHER HAND, THERE WAS STATISTICALLY HIGHER IMPROVEMENT IN THE PGI-I QUESTIONNAIRE IN THE TOT GROUP AFTER 6 MONTHS AND 12 MONTHS WHEN COMPARED WITH THE SIS GROUP. *NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE EVENT INVOLVING THE SOLYX SIS SYSTEM. PLEASE REFER TO MANUFACTURER REPORT #2124215-2024-32095 FOR THE EVENTS INVOLVING THE OBTRYX SYSTEM. *REFERENCE LITERATURE ARTICLE TRANSOBTURATOR VERSUS MINISLING FOR URINARY INCONTINENCE: A RANDOMIZED CONTROLLED TRIA INCLUDED WITH THIS REPORT FOR A FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883526 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention