BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7940345 · Received October 5, 2018

    Report

    Report Number
    2210968-2018-76349
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 12, 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 FOLLOWING INFORMATION. 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 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J (2016) 27: 377¿380, DOI 10.1007/S00192-015-2876-5, PUBLISHED ONLINE: 20 NOVEMBER 2015. (B)(4).

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? NO. 2. DO YOU BELIEVE THAT IT WAS DUE TO ANY DEFICIENCY OF THE ETHICON PRODUCT WHICH CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS AS DESCRIBED IN THE ARTICLE? AS IN THE ARTICLE, THE ANSWER IS UNCERTAIN. THOUGH GIVEN THE TRACK RECORD, THIS IS HIGHLY UNLIKELY. AS THE SURGERY WAS NOT PERFORMED IN OUR HOSPITAL, WE ARE ALSO UNABLE TO PROVIDE INFORMATION IF ANY DEFECT WAS NOTED AT THE TIME OF IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "A FIRST REPORTED CASE OF CLEAR CELL CARCINOMA ASSOCIATED WITH DELAYED EXTRUSION OF MIDURETHRAL TAPE." AUTHOR: HARVARD ZHENJIA LIN & FIONA MEIWEN WU & JEFFREY JEN HUI LOW, KOTAMMA VENKATESWARAN & ROY KWOK WENG NG. CITATION: INT UROGYNECOL J (2016) 27: 377¿380, DOI 10.1007/S00192-015-2876-5, PUBLISHED ONLINE: 20 NOVEMBER 2015. THIS CASE STUDY PRESENTED THE FIRST REPORTED CASE OF CLEAR CELL CARCINOMA ASSOCIATED WITH A MIDURETHRAL TAPE (MUT), THE POSSIBLE HYPOTHESES AND THE MANAGEMENT PITFALLS WE ENCOUNTERED. A (B)(6) WOMAN WITH A MEDICAL HISTORY OF HYPERTENSION HAD UNDERGONE PREVIOUS VAGINA HYSTERECTOMY, ANTERIOR AND POSTERIOR WALL REPAIR, AND A MIDURETHRAL TAPE PROCEDURE USING THE GYNECARE TVT OBTURATOR SYSTEM (GYNECARE; JOHNSON & JOHNSON, SOMERVILLE, NJ, USA) AT ANOTHER LOCAL HOSPITAL 10 YEARS AGO. SHE PRESENTED TO THE EMERGENCY DEPARTMENT FOR DYSURIA OF 1 WEEK¿S DURATION, FREQUENCY, AND NOCTURIA, WHICH PROGRESSED TO ACUTE RETENTION OF URINE. THIS WAS ASSOCIATED WITH FEVER AND HAEMATURIA. VAGINAL EXAMINATION WAS EXTREMELY TENDER. THE ANTERIOR VAGINAL WALL WAS INFLAMED AND INDURATED. THE PREVIOUSLY DEPLOYED TOT HAD EXTRUDED THROUGH THE RIGHT TRANSVERSE VAGINAL SULCUS AND MEASURED 1 CM. THE LEFT INGUINAL LYMPH NODE WAS ENLARGED AND TENDER. SHE WAS TREATED WITH AN INDWELLING CATHETER AND ANTIBIOTICS WITH A VIEW TO EXPLORATION ONCE THE INFLAMMATION SETTLED. TWO WEEKS LATER, THE PATIENT UNDERWENT ELECTIVE PARTIAL TAPE EXCISION EXTENDING FROM BOTH INFERIOR PUBIC RAMI AND RIGID CYSTOSCOPY UNDER GENERAL ANAESTHESIA. SHE WAS SEEN AGAIN 2 WEEKS POSTOPERATIVELY IN THE UROGYNAECOLOGY CLINIC. THE WOUND WAS NOTED TO BE HEALING AND THE SUTURES WERE INTACT. HER SYMPTOMS OF DYSURIA, THOUGH, HAD NOT RESOLVED. TWO MONTHS LATER, SHE PRESENTED AGAIN AT THE UROGYNAECOLOGY CLINIC. THIS TIME, FRIABLE VAGINAL TISSUE WAS SEEN ALONG THE ANTERIOR VAGINA WALL EXTENDING FROM THE EXTERNAL URETHRAL MEATUS FOR ABOUT 3 CM INSIDE THE VAGINA. BEDSIDE ULTRASONOGRAPHY REVEALED AN ECHOGENIC MASS AT THE BLADDER NECK AND BLADDER BASE WITH THE NELATON CATHETER PASSING THROUGH IT. THE URETHROVAGINAL FISTULA WAS DETECTED AND BOTH INGUINAL NODES WERE NOW PALPABLE. THE FRIABLE VAGINAL TISSUE WAS SENT FOR HISTOLOGICAL EXAMINATION, WHICH SHOWED POORLY DIFFERENTIATED HIGH-GRADE CLEAR CELL ADENOCARCINOMA. MAGNETIC RESONANCE IMAGING AND COMPUTED TOMOGRAPHY WERE PERFORMED AND REVEALED A LARGE, LOCALLY INVASIVE PERIURETHRAL MASS WITH EROSION INTO THE ANTERIOR VAGINA WALL, EXTENSIVE NODAL DISEASE INVOLVING THE PELVIC AND PARA-AORTIC NODES AND BONY METASTASIS INVOLVING RIBS AND VERTEBRA. POSSIBLE PRIMARY SITES OF THE MASS COULD BE THE URETHRAL, PERIURETHRAL TISSUE OR THE VAGINA. THE PATIENT UNDERWENT PALLIATIVE RADIOTHERAPY FOR HAEMATURIA. TWO MONTHS LATER, SHE SUBSEQUENTLY DEVELOPED RECURRENT EPISODES OF URINARY TRACT INFECTION AND FAECURIA WAS SEEN IN THE INDWELLING CATHETER. A RECTOVESICAL FISTULA WAS SUSPECTED AND CONFIRMED ON MRI. A DEFUNCTIONING COLOSTOMY WAS CREATED. SHE CONTINUED TO UNDERGO PALLIATIVE CARE 5 MONTHS AFTER THE INITIAL SURGERY. IN CONCLUSION, THE RARITY OF DELAYED TAPE EXPOSURE LED US TO HYPOTHESISE THE POSSIBILITY OF MASS DISPLACEMENT VERSUS CHRONIC INFLAMMATION RESULTING IN MITOTIC CHANGE IN THE SURROUNDING TISSUE. THE AUTHORS RECOMMEND A HIGH INDEX OF SUSPICION AND INVESTIGATING THE PRESENCE OF ANY ABNORMAL LOOKING TISSUE WHEN FACED WITH SUCH A COMPLICATION. IT WOULD ALSO BE HELPFUL FOR UROGYNAECOLOGISTS TO START A REGISTRY OF RARE EVENTS TO INCREASE AWARENESS OF SUCH POSSIBLE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779477 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention