BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15014556 · Received July 14, 2022

    Report

    Report Number
    2210968-2022-05461
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    January 11, 2020
    Report Date
    July 14, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). CITATION: HTTPS://DOI.ORG/10.1016/J.TJOG.2021.09.022.

    Description of Event or Problem · 0

    TITLE: A NOVEL APPROACH WITH CONCOMITANT LAPAROSCOPIC UTERINE ARTERY LIGATION AND D&C AS INITIAL TREATMENT FOR COMPLICATED GESTATIONAL TROPHOBLAST DISEASE IN CESAREAN SCAR AND CERVICAL ECTOPIC PREGNANCIES. CASE REPORT IS PRESENTED WITH TWO UNUSUAL CASES WITH A DIAGNOSIS OF GTD IN ADVANCED LLIEP. THE FIRST CASE HAD CHORIOCARCINOMA IN CESAREAN SCAR AND THE SECOND CASE HAD MOLE PREGNANCY IN CERVIX. BOTH CASES WERE MANAGED WITH LAPAROSCOPY UTERINE ARTERY LIGATIONS FOLLOWED BY TRANSVAGINAL INTRAUTERINE CURETTAGE AND VACUUM ASPIRATION WITH A SMALL AMOUNT OF SURGICAL BLOOD LOSS AND THEN RESUMED REGULAR MENSTRUATION. TO UNDERSTAND THE DIFFERENT SURGICAL APPROACHES AND THEIR POTENTIAL ADVANTAGES IN MANAGING SUCH RARE DISEASES, RELEVANT CASES IN THE LITERATURE WERE REVIEWED. CASE 1: A 27-YEAR-OLD WOMAN, PARA 2, WAS REFERRED TO OUR HOSPITAL BECAUSE OF SUSPICION OF UNEXPLAINED ECTOPIC PREGNANCY. HER LAST PREGNANCY WAS ENDED BY FULL-TERM CESAREAN SECTION 3 YEARS AGO. INITIALLY, INTERMITTENT VAGINAL SPOTTING DEVELOPED, AND PREGNANCY WITH UNKNOWN LOCATION WAS UNEXPECTEDLY FOUND 3 MONTHS AGO. ALTHOUGH NO VISIBLE INTRAUTERINE GESTATIONAL SAC WAS FOUND BY ULTRASOUND SCANNING, SUCTION DILATION AND CURETTAGE WAS PERFORMED TO TERMINATE THE PREGNANCY AND THE HISTOPATHOLOGY REVEALED PRODUCTS OF CONCEPTION AT A LOCAL CLINIC. MRI FURTHER CONFIRMED A HETEROGENEOUS MASS IN THE PREVIOUS CESAREAN SCAR . AN ADVANCED AND COMPLICATED CSP WAS IMPRESSED, AND THE PATIENT UNDERWENT LAPAROSCOPIC SURGERY FOLLOWED BY D&C. AT LAPAROSCOPY, BOTH ADNEXA WERE UNREMARKABLE, BUT ONE LARGE MASS PROTRUDING ANTERIORLY IN THE UTEROVESICAL POUCH WAS NOTED. THE INTERNAL ILIAC ARTERY WAS IDENTIFIED AND THEN TRACED DISTALLY UNTIL THE PROXIMAL PART OF THE UTERINE ARTERY WAS FOUND. THE BLOOD FLOW TO THE UTERUS AND CERVIX WAS BLOCKED BY LIGATION OF BILATERAL UTERINE ARTERIES WITH 1/0 VICRYL SUTURES (POLYGLACTIN 910, ETHICON INC., (B)(4)). THE PERISTALSIS OF THE URETER WAS IDENTIFIED BEFORE AND AFTER ARTERY LIGATION. A SIMILAR PROCEDURE WAS PERFORMED ON THE CONTRALATERAL SIDE. THEN THE GESTATIONAL TISSUES IN CSP ISTHMOCELE WERE REMOVED BY TRANSVAGINAL D&C WITH VACUUM ASPIRATION SMOOTHLY UNDER LAPAROSCOPY GUIDED. UTEROTONIC AGENT WITH OXYTOCIN WAS GIVEN DURING THE PROCEDURE TO ENHANCE THE UTERINE CONTRACTION. IN CONCLUSION ECTOPIC GTD IN CSP AND CP IS RARE AND LACK OF UNIVERSAL CONSENSUS ON OPTIMAL MANAGEMENT. IN INITIAL SURGICAL TREATMENT, COMBINATION OF LAPAROSCOPIC UTERINE ARTERY LIGATIONS FOLLOWED BY D&C IS HIGHLY RECOMMENDED IN SELECTED PATIENTS. THE OBVIOUS ADVANTAGES INCLUDE CONVENIENCE WITHOUT NEED OF UAE, TIME-SAVING, MINIMAL SURGERY-RELATED BLOOD LOSS AND POTENTIAL FERTILITY PRESERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285627 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention