BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 8476563 · Received April 2, 2019

    Report

    Report Number
    2210968-2019-79932
    Event Type
    Injury
    Date Received
    April 2, 2019
    Report Date
    March 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. THE 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 (VICRYL 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 (VICRYL SUTURE OR ETHIBOND SUTURE) USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: THE MODIFIED LAPAROSCOPIC KEYHOLE PARASTOMAL HERNIA REPAIR WITH IN SITU RE-OSTOMY HAS LOW RECURRENCE RATE AUTHORS: ZHIBO YAN, HAIFENG ZHANG, HANXIANG ZHAN, DONG WU, YUGANG CHENG, QUNZHENG WU, GUANGYONG ZHANG CITATION: HERNIA (2018) 22:685¿690. DOI HTTPS://DOI.ORG/10.1007/S10029-018-1789-X. THIS STUDY AIMED TO PRESENT A MODIFIED LAPAROSCOPIC KEYHOLE PARASTOMAL HERNIA REPAIR TECHNIQUE WITH IN SITU REOSTOMY AND SHOW ITS SAFETY AND FEASIBILITY AT A MID-TERM FOLLOW-UP. FROM NOVEMBER 2011 TO DECEMBER 2016, 65 CONSECUTIVE PATIENTS (MALE 40 AND FEMALE 25; MEAN AGE 65 ±1.0 YEARS; BMI 28.5 ± 0.40 KG/M2) UNDERWENT SUCCESSFUL HERNIA REPAIR VIA A MODIFIED LAPAROSCOPIC KEYHOLE WITH IN SITU RE-OSTOMY. THE MESH WAS FASHIONED WITH A CENTRAL 2-CM KEYHOLE AND MARKED WITH ORIENTATION. THE STOMAL BOWEL WAS DELIVERED THROUGH THE KEYHOLE, AND THE MESH WAS STITCHED TO THE SEROMUSCULAR LAYER OF THE STOMAL BOWEL WITH CONTINUOUS STITCHES USING 3-0 COATED VICRYL PLUS (ETHICON) ANTIBACTERIAL SUTURE MATERIAL. THE MESH WAS THEN PLACED INTRAPERITONEALLY, AND THE HERNIAL RING WAS NARROWED WITH FOUR TO EIGHT 1-0 ETHIBOND EXCEL POLYESTER SUTURES (ETHICON). THE MESH WAS FURTHER STITCHED TO THE STOMAL TUBE AND HERNIAL RING WITH 2-0 ETHIBOND SUTURES (ETHICON) AT THE SUPERIOR AND INFERIOR MARGINS IN THE HORIZONTAL PLANE. REPORTED PERIOPERATIVE COMPLICATIONS INCLUDED SEROMA (N-2) BOTH TREATED BY PERCUTANEOUS DRAINAGE, ILEUS (N-3) ALL CURED USING CONSERVATIVE TREATMENT AND INTESTINAL PERFORATION/SMALL BOWEL INJURY (N-1) RESCUED BY INTESTINAL RESECTION AND ENTEROENTEROSTOMY. REPORTED COMPLICATIONS DURING FOLLOW UP INCLUDED HERNIA RECURRENCE (N-1), STENOSIS OF THE COLONIC STOMA CAUSING DYSFUNCTIONAL DEFECATION (N-1) AND PATIENT DISSATISFACTION BECAUSE OF PERSISTENT PAIN AT THE MESH SITE (N-1). IN CONCLUSION, MODIFIED LAPAROSCOPIC KEYHOLE PARASTOMAL HERNIA REPAIR WITH IN SITU RE-OSTOMY IS A SAFE PROCEDURE WITH A LOW RECURRENCE RATE AT THE MID-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265275 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention