BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7371628 · Received March 26, 2018

    Report

    Report Number
    2210968-2018-71661
    Event Type
    Injury
    Date Received
    March 26, 2018
    Report Date
    March 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY OF THE ETHICON PRODUCT VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CITATION: ANN THORAC SURG 2016;101:1131¿8; DOI: HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2015.09.094. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: EMBEDDED THREE-LAYER ESOPHAGOGASTRIC ANASTOMOSIS REDUCES MORBIDITY AND IMPROVES SHORT-TERM OUTCOMES AFTER ESOPHAGECTOMY FOR CANCER THE STUDY AIMED TO COMPARE TWO TYPES OF CERVICAL ESOPHAGOGASTRIC ANASTOMOSES WITH RESPECT TO THE REDUCTION OF POSTOPERATIVE ANASTOMOTIC LEAKS, STENOSIS, AND GASTROESOPHAGEAL REFLUX. FROM JUN 2010 TO SEP 2013, 339 PATIENTS WHO UNDERWENT CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS AFTER THORACO LAPAROSCOPIC ESOPHAGECTOMY FOR ESOPHAGEAL CANCER. IN THESE POPULATION, 173 PATIENTS (N=99 MALE, N=74 FEMALE; 61.2±8.3 YEARS) UNDERGO CONVENTIONAL TWO-LAYER ANASTOMOSES (CONVENTIONAL GROUP) AND 166 PATIENTS (N=107 MALE, N=59 FEMALE; MEAN AGE SD 60.8±8.2 YEARS) HAD EMBEDDED THREE-LAYER ANASTOMOSES (EMBEDDED GROUP). BOTH GROUPS UTILIZED 4-0 VICRYL SUTURES IN COMPLETING THE ANASTOMOSIS. IN CONVENTIONAL GROUP, THE EMBEDDING AND FUNDOPLICATION WERE NOT PERFORMED. IN CONVENTIONAL GROUP, COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGES (N=13), BENIGN ANASTOMOTIC STRICTURE (N=22) AND PNEUMONIA (N=27). IN CONVENTIONAL GROUP, COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGES (N=4), BENIGN ANASTOMOTIC STRICTURE (N=8) AND PNEUMONIA (N=14). PATIENTS WITH ANASTOMOTIC LEAKAGE RECEIVED NASOGASTRIC DECOMPRESSION AND CERVICAL DRAINAGE. PATIENTS WITH ANASTOMOTIC STRICTURE UNDERWENT DILATATION UNDER SEDATION WITH SAVARY-GILLIARD GUM ELASTIC BOUGIES TO A MAXIMAL DIAMETER OF 15MM. IN BOTH GROUPS, PNEUMONIA CORRELATED STRONGLY WITH ANASTOMOTIC LEAKAGE. THE NEW EMBEDDED THREE-LAYER ESOPHAGOGASTRIC ANASTOMOSIS OFFERS SEVERAL ADVANTAGES AND REDUCES THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS SUCH AS ANASTOMOTIC LEAK, STRICTURE, AND GASTROESOPHAGEAL REFLUX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215194 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention