BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 13290160 · Received January 19, 2022

    Report

    Report Number
    2210968-2022-00510
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    December 8, 2020
    Report Date
    January 19, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-00511. CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY (2021); 257:59¿63. HTTPS://DOI.ORG/10.1016/J.EJOGRB.2020.12.012.

    Description of Event or Problem · 0

    TITLE: FERTILITY OUTCOMES AFTER PRECONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE FOR SECOND-TRIMESTER PREGNANCY LOSSES THE AIM OF THIS RETROSPECTIVE OBSERVATIONAL COHORT STUDY WAS TO EVALUATE THE CONCEPTION RATE AND TIME TO CONCEPTION OR FAILURE TO CONCEIVE AFTER PRECONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE (LAC). A TOTAL OF 28 FEMALE PATIENTS (AGE RANGED 21 TO 42 YEARS) WHO UNDERWENT PRECONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE (LAC) IN THE NONPREGNANT STATE FOR A SECOND-TRIMESTER PREGNANCY LOSS BETWEEN JUNE 2012 AND FEBRUARY 2020 WERE INCLUDED. THE VESICOUTERINE PERITONEUM WAS INCISED USING AN ULTRACISION HARMONIC SCALPEL (SOMA TECH INTL., CT, USA) ACROSS THE LOWER UTERINE SEGMENT, STARTING LATERALLY AND EVENTUALLY REACHING THE MIDLINE, AS MOST CASES HAD SEVERE ADHESIONS BETWEEN THE BLADDER AND LOWER UTERINE SEGMENT DUE TO PREVIOUS CESAREAN SECTIONS. A 5-MM MERSILENE TAPE (ETHICON) WITH STRAIGHT NEEDLES WAS INTRODUCED INTO THE ABDOMEN THROUGH THE 10-MM UMBILICAL PORT. THE NEEDLES AT BOTH ENDS OF THE TAPE WERE PASSED MEDIAL TO THE UTERINE VESSELS BILATERALLY, AT THE LEVEL OF THE INTERNAL CERVICAL OS FROM POSTERIOR TO ANTERIOR; THE INSERTION SITES WERE 2 CM SUPERIOR AND 1 CM LATERAL TO THE ATTACHMENT OF THE UTEROSACRAL LIGAMENTS TO THE UTERUS. ATTENTION WAS PAID TO ENSURE THAT THE TIPS OF THE NEEDLES EXITED MEDIAL TO THE UTERINE ARTERIES EXPOSED ANTERIORLY. THE MERSILENE TAPE WAS THEN SECURED WITH FIVE OR SIX KNOTS TIED INTRACORPOREALLY, ANTERIOR TO THE CERVIX. THE NEEDLES WERE CUT AND REMOVED. THE VESICOUTERINE PERITONEUM WAS CLOSED OVER THE CERCLAGE SUTURE WITH A CONTINUOUS 2-0 VICRYL (ETHICON) SUTURE. REPORTED COMPLICATIONS INCLUDE INADVERTENT PASSAGE OF THE MERSILENE TAPE THROUGH THE CERVICAL CANAL (N=1) REQUIRING THE USE OF OFFICE HYSTEROSCOPY DURING INSERTION OF THE MERSILENE TAPE NEEDLES, AND MISSED ABORTION AT 7 GESTATIONAL WEEKS (N=2). IN CONCLUSION, IN PATIENTS WITH CERVICAL INCOMPETENCE, LAC IS A VERY EFFECTIVE INTERVENTION TO SUSTAIN PREGNANCY TO THE STAGE OF VIABILITY. IF PLACED DURING THE PRECONCEPTIONAL PERIOD, IT DOES NOT DELAY ACHIEVING PREGNANCY AND DOES NOT HAVE A NEGATIVE IMPACT ON THE CHANCES OF CONCEPTION. THIS MAY BE REASSURING TO WOMEN UNDERGOING THIS PROCEDURE BEFORE THEY ACHIEVE A PREGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051544 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention