BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7848451 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75651
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (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 PRODUCT (ETHIBOND SUTURE) USED IN THIS PROCEDURE? CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS. 2017; 41: 505¿510. DOI: HTTPS://DOI.ORG/10.1016/J.IJSCR.2017.11.040. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : MANAGEMENT OF GASTRIC CONDUIT RETENTION FOLLOWING HYBRID AND MINIMALLY INVASIVE ESOPHAGECTOMY FOR ESOPHAGEAL CANCER:TWO RETROSPECTIVE CASE SERIES". AUTHOR: INGVILD FARNESA,*, EGIL JOHNSONA,B, HANS-OLAF JOHANNESSEN. CITATION: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS. 2017; 41: 505¿510. DOI: HTTPS://DOI.ORG/10.1016/J.IJSCR.2017.11.040. FOLLOWING ESOPHAGECTOMY, ABOUT 5% OF PATIENTS EXPERIENCE LONG-TERM GASTRIC CONDUIT RETENTION. THE AUTHORS REPORTED 2 PATIENTS WITH SURGICAL CORRECTION FOR THIS PROBLEMATIC CONDITION. THIS CASE SERIES IS A RETROSPECTIVE, NON-CONSECUTIVE SINGLE CENTER REPORT. THE AUTHORS REPORTED A (B)(6) OBESE MAN (BMI: 33.3) WITH A LOWER ESOPHAGEAL CANCER AND UNDERWENT MINIMALLY INVASIVE ESOPHAGECTOMIES (MIE) IN THE LEFT LATERAL POSITION WITH A STAPLED CIRCULAR ANASTOMOSIS (ESOPHAGO-GASTROSTOMY) AT A LEVEL JUST ABOVE THE TRACHEAL BIFURCATION. AT 27 MONTHS POSTOPERATIVELY, THE PATIENT HAD REDUNDANT CONDUIT WITH A RELATIVELY LONG DISTAL SEGMENT, INCLUDING THE PYLORUS, LYING ON THE DIAPHRAGM WITH ONLY MINOR PASSAGE OF CONTRAST INTO THE ABDOMEN. DURING THE SURGICAL CORRECTION, THE PATIENT UNDERWENT THE FIRST REOPERATION LAPAROSCOPICALLY WITH PARTIAL TRANSHIATAL MOBILIZATION, REDUCTION, AND FIXATION OF THE CONDUIT TO THE DIAPHRAGMATIC CRURA WITH 6 ETHIBOND 1-0 SUTURES (ETHICON). A TRANSIENT IMPROVEMENT OF ORAL INTAKE FOLLOWED BUT THE PATIENT¿S GASTRIC CONDUIT RETENTION REOCCURRED WITHOUT OPPORTUNITY FOR EATING AND DAILY INTAKE OF ONLY MINOR FLUID VOLUMES (GASTRIC CONDUIT RETENTION RECURRENCE WITHOUT THE OPPORTUNITY FOR EATING AND DAILY INTAKE OF ONLY MINOR FLUID VOLUMES). A 12.5 CM LONG FENESTRATED WALL STENT WAS CENTRALLY PLACED IN THE PYLORUS AND FURTHER SUTURED TO THE DUODENUM BY LAPAROSCOPY THEREBY MINIMIZING RISK FOR STENT MIGRATION. UNFORTUNATELY, THE STENT HAD TO BE REMOVED ENDOSCOPICALLY AFTER 9 DAYS DUE TO DISLOCATION INTO THE GASTRIC CONDUIT. THE PATIENT¿S CLINICAL SYMPTOMS WERE STILL UNRESOLVED. THREE WEEKS LATER, THE PATIENT UNDERWENT A THIRD REOPERATION IN WHICH 6¿8 CM OF REDUNDANT CONDUIT WAS REDUCED INTO THE ABDOMEN VIA A RIGHT LOWER THORACOTOMY AND AN UPPER MINI LAPAROTOMY. SOME ADHESIONS WERE DISSECTED, AND THE STRAIGHTENED TUBE-LIKE CONDUIT WAS FIXED TO THE OESOPHAGEAL HIATUS AND CRURA BY INTERRUPTED TYCRON SUTURES. IT WAS REPORTED THAT WITHIN A FEW DAYS THE PATIENT COULD EAT AND DRINK CAREFULLY WITHOUT ANY NEED FOR ADDITIONAL NUTRITION TO MAINTAIN ADEQUATE CALORIC INTAKE. THE PATIENT HAD NO SYMPTOMS OF RETENTION AND WAS DISCHARGED FROM HOSPITAL AFTER 13 DAYS. IT WAS REPORTED THAT THE LAPAROSCOPIC PARTIAL TRANSHIATAL MOBILIZATION AND FIXATION OF THE CONDUIT WAS NOT SUFFICIENT TO RESOLVE THE RETENTION. THE FOLLOWING PROCEDURE OF TRANSPYLORIC STENTING FAILED BECAUSE OF THE PROXIMAL STENT MIGRATION, DESPITE ITS FIXATION TO DUODENUM BY LAPAROSCOPIC SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690236 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention