BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19047092 · Received April 4, 2024

    Report

    Report Number
    2210968-2024-03901
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    April 1, 2023
    Report Date
    April 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. 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 OF THE ETHICON PRODUCTS INVOLVED (VICRYL SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: CERVICAL INFECTION AT THE SUTURE SITE, TEMPORARY ASPIRATION TO FLUIDS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: LARYNGOSCOPE, 133:883¿889, 2023; DOI: 10.1002/LARY.30293 . THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: DILATION, STEROID INJECTION, AND COUGH EXERCISE FOR CORRECTION OF POSTERIOR GLOTTIC STENOSIS THE OBJECTIVE OF THE STUDY IS TO DESCRIBE THE DISCO PROTOCOL (DILATION, STEROID INJECTION, AND POST-OPERATIVE COUGH EXERCISE); A NOVEL TREATMENT FOR POSTERIOR GLOTTIC STENOSIS. BETWEEN JANUARY 2018 AND DECEMBER 2021, 17 PATIENTS TREATED FOR POSTERIOR GLOTTIC STENOSIS WERE INCLUDED IN THE STUDY. THERE WERE 12 MALES AND 5 FEMALES WITH A MEAN AGE OF MEAN AGE WAS 54.5 (MEDIAN: 56, RANGE: 26¿74). DISCO INVOLVES THE FOLLOWING: SCAR RELEASE, GLOTTIC DILATION, AND STEROID INJECTION, FOLLOWED BY POST-OPERATIVE COUGH AS GLOTTIC PHYSICAL THERAPY. A COMPETITOR BALLOON DILATOR WAS USED (MANUFACTURER: BOSTON SCIENTIFIC). THE POSTERIOR GLOTTIS WAS PALPATED FOR THE SECOND TIME AND RE-ASSESSED FOR PASSIVE ABDUCTION MOVEMENT OF THE CRICOARYTENOID JOINTS. IN CASE ONE OR BOTH JOINTS WERE RESISTANT TO PASSIVE ABDUCTION, AN ADDITIONAL SUB-MUCOSAL ARYTENOIDECTOMY WITH LATERALIZATION SUTURE (SMALS) WAS PERFORMED ON THE MORE RESISTANT SIDE. THE SMALS¿ TECHNIQUE INVOLVES SUBMUCOSAL SUBTOTAL ARYTENOIDECTOMY WHEREAS PRESERVING AN INFERIORLY BASED MEDIAL MUCOSAL FLAP. THE FLAP IS THEN LATERALIZED USING TWO 2¿0 VICRYL (ETHICON) LATERALIZATION SUTURES TO COVER THE ARYTENOIDECTOMY SURGICAL BED. OBSERVATION OF AT LEAST ONE DAY, REGULAR ORAL INTAKE RESUMED WITHIN 24 H. VOICE REST IS UNNECESSARY AND PATIENTS WERE ENCOURAGED TO ACTIVELY MOBILIZE THEIR LARYNX AND COUGH REGULARLY, ACCORDING TO THE DISCO PROTOCOL. IF POSSIBLE, PATIENTS WERE ENCOURAGED TO CAP THEIR CANNULA WHILE AWAKE. REPORTED COMPLICATIONS INCLUDED CERVICAL INFECTION AT THE SUTURE SITE (N=1), AND TEMPORARY ASPIRATION TO FLUIDS (N=1). IN CONCLUSION, THE DISCO PROTOCOL IS A NOVEL, EFFECTIVE AND SAFE APPROACH FOR PGS CORRECTION THAT CAN BE EASILY APPLIED. IT CAN RESTORE VOCAL FOLD MOBILITY AND MAY EXPAND THE GLOTTIC AIRWAY WITHOUT CAUSING GLOTTIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373946 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention