BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7346387 · Received March 16, 2018

    Report

    Report Number
    2210968-2018-71493
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    September 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: AS THE FIRST AUTHOR OF THIS ARTICLE I WOULD LIKE TO GIVE YOU THE FEEDBACK THAT, I DON'T BELIEVE THAT YOUR PRODUCTS CONTRIBUTED TO ANY ADVERSE EVENTS IN ANY WAY IN THE PROJECT. IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-71493 IS NOT REPORTABLE.

    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, PROLENE OR MONOCRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, WOUND INFECTION? CITATION: OBES SURG. 2017; 27:3320 3326. DOI: 10.1007/S11695-017-2941-X .

    Description of Event or Problem · 1

    TITLE: BIKINI LINE SLEEVE GASTRECTOMY: INITIAL REPORT. BARIATRIC SURGERY HAS BEEN CONTINUOUSLY EVOLVING WITH MORE THAN 50 PROCEDURES DESCRIBED OVER THE PAST DECADES. NONETHELESS, BARIATRIC SURGEONS ARE STILL IN SEARCH FOR THE IDEAL BARIATRIC SURGICAL PROCEDURE. IN PARALLEL, THERE WAS A HAND-IN-HAND EVOLUTION IN THE MODE OF ACCESS IN BARIATRIC SURGERY, WHERE SEVERAL REPORTS HAVE DISCUSSED THE POTENTIAL FOR REDUCING PORT ACCESS IN LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) BY EITHER ADOPTING THREE PORTS OR A SINGLE PORT APPROACH. THE AUTHOR REPORTED A NOVEL APPROACH TO THE LSG WHERE WE PLACE THE TROCARS AT THE BIKINI LINE IN WHAT WE DESCRIBED AS BIKINI LINE SLEEVE GASTRECTOMY (BLSG). THE PRESENT WORK IS A PROSPECTIVE, PILOT STUDY ON THE USE OF BLSG IN PATIENTS AND TO EVALUATE THE FEASIBILITY AND SAFETY OF THIS TECHNIQUE. A TOTAL OF 28 PATIENTS (22 FEMALES 6 MALES; AGE RANGE: 22 TO 40 YEARS OLD) WERE FOUND CANDIDATE FOR BLSG. DURING THE SUTURING PHASE, THE SURGEON ROUTINELY COVER THE STAPLE LINE WITH A PROLENE 3-0 SUTURE. THE RESECTED STOMACH WAS EXTRACTED FROM THE UMBILICAL PORT, AND WE ROUTINELY CLOSED THIS PORT SITE WITH A VICRYL 0 SUTURE. ALL SCARS WERE CLOSED USING AN ABSORBABLE MONOCRYL 3-0 SUTURE. REPORTED COMPLICATION INCLUDED A MINOR WOUND INFECTION IN 1 PATIENT. IT WAS REPORTED THAT THE SUTURING PHASE WAS MORE DEMANDING BECAUSE OF THE RELATIVELY LONGER DISTANCE TO THE ESOPHAGOGASTRIC JUNCTION, BUT THIS BECAME MORE COMFORTABLE AS WE PROGRESSED TOWARDS THE ANTRUM. IT WAS CONCLUDED THAT THE MAIN BENEFIT OF BLSG IS IMPROVED COSMESIS. BLSG WAS FOUND TO BE POTENTIALLY SAFE, FEASIBLE, AND EFFECTIVE WITH A FAVORABLE AESTHETIC OUTCOME. IT COULD POSSIBLY BE OFFERED TO A SELECTED GROUP OF PATIENTS THAT ARE CONSCIOUS ABOUT THEIR SCAR APPEARANCE. TREATMENT FOR THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187414 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention