BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 8060888 · Received November 12, 2018

    Report

    Report Number
    2210968-2018-77095
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    October 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (TENSION-FREE VAGINAL TAPE-OBTURATOR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY. 2013; 171. 376¿380. DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2013.09.018. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: "MODIFIED PRE-PUBIC TVT-OBTURATOR TAPE PROCEDURE VERSUS THE CONVENTIONAL METHOD: A PRELIMINARY STUDY.." THE OBJECTIVES OF THE STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF THE MODIFIED PRE-PUBIC TENSION-FREE VAGINAL TAPE OBTURATOR (PTVT-O) SYSTEM PROCEDURE WITH THE ORIGINAL TVT-O METHODS. A TOTAL OF 190 PATIENTS WITH URODYNAMIC STRESS INCONTINENCE (USI) WERE INCLUDED IN THIS STUDY. OF WHICH, 93 PATIENTS (AGE: 57.7 ± 11.3; BMI: 25.3 ± 3.4) WERE IN THE TVT-O GROUP AND 97 PATIENTS (AGE: 56.3 ± 11.3; BMI: 24.7 ± 3.4) IN THE PTVT-O GROUP. DURING THE PROCEDURE IN THE TVT-O GROUP, AFTER A BONE CONTACT WAS PERCEIVED, THE GYNECARE TVT-OBTURATOR SYSTEM (ETHICON) INTRODUCER WAS THEN PUSHED IN THROUGH THE PRE-FORMED DISSECTION TUNNEL UNTIL IT REACHED AND PERFORATED THE OBTURATOR MEMBRANE. THE EXIT POINT WAS ALWAYS LOCATED 2 CM ABOVE A HORIZONTAL LINE AT THE LEVEL OF THE URETHRAL MEATUS AND 2 CM OUTSIDE THE THIGH FOLD. THE SAME PROCEDURE WAS DONE ON THE OTHER SIDE. FINALLY, THE VAGINAL AND THIGH WOUNDS WERE CLOSED AFTER THE ENDS OF TVT-O TAPE HAD BEEN CUT SUBCUTANEOUSLY. IN THE PTVT-O GROUP, ALL THE ORIGINAL METHODS ARE SIMILAR WITH ONLY SUBTLE DIFFERENCES IN THE EXIT WOUNDS. THE EXIT POINTS WERE MARKED 2 CM LATERALLY AND 10¿12 CM ABOVE A HORIZONTAL LINE AT THE LEVEL OF THE CLITORIS. AFTER THE GYNECARE TVT-OBTURATOR SYSTEM (ETHICON) INTRODUCER PERFORATED THE OBTURATOR MEMBRANE, THE HELICAL TROCAR TURNED UP TO TRAVEL UNDER THE SUBCUTANEOUS TISSUE AND REACHED PRE-PUBICALLY TO THE ABDOMEN. THAT IS THE REASON WHY IT WAS CALLED PTVT-O PROCEDURE. IN THE TVT-O GROUP, REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED VAGINAL EROSION (N-2), POST-OPERATIVE DE NOVO URGENCY (N-1), POST-OPERATIVE DE NOVO BLADDER OUTLET OBSTRUCTION (N-2), AND POST-OPERATIVE URINARY TRACT INFECTION (N-14). IN THE PTVT-O GROUP, REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED VAGINAL EROSION (N-3), POST-OPERATIVE DE NOVO BLADDER OUTLET OBSTRUCTION (N-1), POST-OPERATIVE URINARY TRACT INFECTION (N-11). IN CONCLUSION, THE RESULTS OF THIS STUDY SUGGEST THAT THE MODIFIED PROCEDURE IS A SAFE AND EFFECTIVE TREATMENT FOR FEMALE SUI. IT HAS AN ADVANTAGE OVER THE ORIGINAL TVT-O WITH BETTER SURGICAL EFFICACY AND COMPARABLE POSTOPERATIVE PAIN, ALTHOUGH THE FOLLOW-UP TIMES IN THIS STUDY ARE DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901234 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention