BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9857257 · Received March 19, 2020

    Report

    Report Number
    2210968-2020-02238
    Event Type
    Injury
    Date Received
    March 19, 2020
    Report Date
    February 24, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    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. 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 ETHICON PRODUCTS (PDS SUTURE OR ETHIBOND SUTURE) 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 (PDS SUTURE OR ETHIBOND SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: DIS COLON RECTUM 2019; 62: 1512¿1517; DOI: 10.1097/DCR.0000000000001510. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE:IMPACT OF SUTURE TYPE ON EROSION RATE AFTER LAPAROSCOPIC VENTRAL MESH RECTOPEXY: A CASE-MATCHED STUDY". AUTHOR/S: PATRICIA TEJEDOR, M.D., PH.D. ¿ IAN LINDSEY, M.B.B.S., F.R.A.C.S. OLIVER M. JONES, D.M., F.R.C.S. ¿ HELEN J.S. JONES, M.B.CH.B., F.R.C.S.ED. KIM GORISSEN, M.D. ¿ MARTA PENNA, M.B.B.S., B.SC.(HONS.), M.R.C.S. CHRIS CUNNINGHAM, B.SC.(HONS.), M.B.CH.B., M.D., F.R.C.S.ED. CITATION: DIS COLON RECTUM 2019; 62: 1512¿1517; DOI: 10.1097/DCR.0000000000001510. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE RATES OF MESH-RELATED COMPLICATIONS AFTER LAPAROSCOPIC VENTRAL MESH RECTOPEXY, ACCORDING TO THE TYPE OF SUTURE USED IN FIXATION OF MESH. BETWEEN 2010 AND 2017, A TOTAL OF 495 PATIENTS UNDERGONE LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR). THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TYPE OF SUTURE USED DURING INTERVENTION: ETHIBOND ¿ CONTROL GROUP (FEMALE = 93, MALE = 7; MEAN AGE=60 YEARS) VERSUS PDS ¿ CASE GROUP (FEMALE =91, MALE = 9; MEAN AGE = 66 YEARS). THE PATIENTS UNDERWENT LVMR WITH SYNTHETIC, NONABSORBABLE MESH FIXED TO THE PROMONTORY USING PROTACK STAPLES AND SECURED TO THE RECTUM AND THE VAGINA USING NONABSORBABLE MESH (ETHIBOND EXCEL 00; ETHICON) EITHER ALONE OR IN COMBINATION WITH ABSORBABLE SUTURES TO THE VAGINA OR EXCLUSIVELY ABSORBABLE SUTURES (PDS 3/0; ETHICON). REPORTED COMPLICATION INCLUDED INTRAOPERATIVE PORT-SITE BLEEDING (N=?); IN CONTROL GROUP, COMPLICATIONS INCLUDED MESH EROSION (N=6) IN WHICH THERE WERE 4 EROSIONS INTO THE RECTUM WALL AND 2 INTO THE VAGINA. THE PATIENTS UNDERWENT A LOCAL REMOVAL OR TRIMMING OF THE STITCH OR EXPOSED MESH UNDER DIRECT VISION OR USING TRANSANAL ENDOSCOPIC MICROSURGERY IN 2 PATIENTS; OBSTRUCTIONS ADHESIONS (N=2). IN CONCLUSION, MESH-RELATED COMPLICATIONS ARE REDUCED USING ABSORBABLE SUTURES COMPARED WITH NONABSORBABLE SUTURES WHEN PERFORMING LAPAROSCOPIC VENTRAL MESH RECTOPEXY WITH SYNTHETIC MESH WITHOUT AN INCREASE IN RECTOPEXY FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317920 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention