BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    MDR report key: 9243390 · Received October 27, 2019

    Report

    Report Number
    2210968-2019-89086
    Event Type
    Injury
    Date Received
    October 27, 2019
    Report Date
    October 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 PRODUCT (TENSION-FREE VAGINAL TAPE-ABBREVO) 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 (TENSION-FREE VAGINAL TAPE-ABBREVO) INVOLVED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY. 2018; 230: 141¿146 .(B)(4).

    Description of Event or Problem · 1

    TITLE : TVT ABBREVO AND MINIARC SUBURETHRAL SLING IN WOMEN WITH STRESS URINARY INCONTINENCE ¿ A RANDOMISED CONTROLLED TRIAL SINGLE INCISION SLINGS (SIS) WERE INTRODUCED IN AN ATTEMPT TO DECREASE THE COMPLICATIONS ASSOCIATED WITH RETROPUBIC AND TRANSOBTURATOR SLINGS. THE TVT ABBREVO IS A MODIFICATION OF THE TVT-O WITH A REDUCED LENGTH AND LESS IMMEDIATE POSTOPERATIVE PAIN. THE OBJECTIVES OF THE STUDY WAS TO EVALUATE THE OBJECTIVES AND SUBJECTIVE OUTCOMES OF MINIARC SIS AND TVT ABBREVO MIDURETHRAL SLING (MUS) IN WOMEN WITH STRESS URINARY INCONTINENCE. BETWEEN FEBRUARY 2011 TO JANUARY 2016, A TOTAL OF 246 WOMEN WERE RANDOMIZED TO RECEIVE MINIARC (121 PATIENTS; MEAN AGE: 50.1 ± 10.1; BMI: 25.7 ± 5.0) OR TVT ABBREVO (ETHICON; 125 PATIENTS; MEAN AGE: 51.0 ± 10.0 YEARS; BMI: 26.1 ± 5.0). DURING THE PROCEDURE, TVT ABBREVO (ETHICON) OR MINIARC WERE PERFORMED IN A STANDARDIZED FASHION FOLLOWING MANUFACTURER¿S INSTRUCTIONS, TOGETHER WITH ANY CONCOMITANT PROLAPSE SURGERY. SURGEONS WERE ALREADY PROFICIENT IN BOTH MIDURETHRAL SLINGS HAVING PERFORMED MORE THAN 20 OF EACH AT LEAST. ALL WOMEN UNDERWENT GENERAL AND LOCAL ANESTHESIA FOR THEIR SURGERIES AND HAD A CYSTOURETHROSCOPY ROUTINELY. IN THE TVT ABBREVO GROUP, REPORTED COMPLICATIONS INCLUDED GROIN PAIN (43.5%), VAGINAL BLEEDING (53.4%), MESH EXPOSURE (N-3) WHICH REQUIRED MESH EXCISION IN 2 PATIENTS. THE THIRD PATIENT WAS MANAGED SURGICALLY CREATING A SMALL SKIN FLAP TO COVER THE AREA EXPOSED, DIFFICULTY VOIDING POSTOPERATIVELY (N-1) WHICH REQUIRED SLING LOOSENING, VAGINAL PAIN (N-1) WHICH REQUIRED REMOVAL OF THE TVT ABBREVO SLING. THIS STUDY IS THE FIRST REPORTED COMPARISON OF A SINGLE INCISION SLING, MINIARC WITH TVT ABBREVO, A TRANSOBTURATOR SLING WITH A SHORTENED LENGTH. IT DEMONSTRATED VERY GOOD OBJECTIVE CURE RATES OF 93¿96% FOR BOTH TVT ABBREVO AND MINARC SLING. AT 6 AND 12 MONTH FOLLOW-UP, THE OBJECTIVE AND SUBJECTIVE CURE RATES WERE SIMILAR AND GENERALLY HIGH IN BOTH GROUPS WITH A LOW COMPLICATION RATE, WHICH IS CONSISTENT WITH REPORTED RESULTS FROM ANOTHER SIMILAR RCT AND SYSTEMATIC REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037685 TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention