BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18790674 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-01985
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    October 21, 2021
    Report Date
    February 27, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-01984 AND 2210968-2024-01986 CITATION: AMERICAN JOURNAL OF OTOLARYNGOLOGY¿HEAD AND NECK MEDICINE AND SURGERY (2022);43:103275. HTTPS://DOI.ORG/10.1016/J.AMJOTO.2021.103275.

    Description of Event or Problem · 0

    TITLE: VARIABLES PREDICTIVE OF SURGICAL OUTCOMES AFTER HYOID MYOTOMY WITH SUSPENSION TO THYROID CARTILAGE. THE AIM OF THIS RETROSPECTIVE, NON-RANDOMIZED STUDY IS TO EVALUATE VARIABLES PREDICTING IMPROVEMENT IN OBSTRUCTIVE SLEEP APNEA (OSA) WITH HYOID SUSPENSION TO THYROID CARTILAGE 4-SUTURE TECHNIQUE. BETWEEN (B)(6) 2011 TO (B)(6) 2019, A TOTAL OF 60 PATIENTS [47 MALE AND 13 FEMALE; MEAN AGE WAS 50.8 ± 10.2 YEARS (RANGE 23¿78); MEAN BMI WAS 36.2 ± 6.5 KG/M2 (RANGE 23.0¿53.0)] WITH OSA CONFIRMED BY POLYSOMNOGRAPHY (PSG) WHO UNDERWENT HYOID SUSPENSION TO THYROID CARTILAGE WERE INCLUDED IN THE STUDY. FOUR 0 BLUE POLYPROPYLENE SUTURES (PROLENE, ETHICON, SOMERVILLE, NJ) SUTURES WERE INDIVIDUALLY PASSED THROUGH THE THYROID CARTILAGE 1 CM FROM THE SUPERIOR BORDER, TWO JUST OFF MIDLINE AND TWO LOCATED 1 CM FROM MIDLINE, EXITING JUST POSTERIOR TO THE THYROID LAMINA TO AVOID ENTERING THE LARYNGEAL LUMEN. THE MEDIAL AND LATERAL SUTURES WERE PASSED AROUND THE HYOID BONE IN MIDLINE FROM INFERIOR TO SUPERIOR AND TAGGED. THE SHOULDER ROLL WAS REMOVED, AND THE NECK PLACED IN MILD FLEXION. THE THYROID CARTILAGE WAS DRAWN SUPERIORLY WITH A SKIN HOOK WHILE THE HYOID BONE WAS RETRACTED ANTERIORLY AND INFERIORLY OVERLYING THE THYROID NOTCH. THE POLYPROPYLENE SUTURES WERE THEN TIED SECURELY IN A SYSTEMATIC FASHION STARTING FROM THE MEDIAL SUTURES TO THE LATERAL SUTURES TO FIX THE HYOID BONE TO THE THYROID CARTILAGE. THE STRAP MUSCLES, PLATYSMA, AND SKIN WERE CLOSED WITH MULTI-LAYER TECHNIQUE WITH 3-0 POLYGLACTIN (VICRYL, ETHICON, SOMERVILLE, NJ) AND 5-0 FAST GUT (ETHICON, SOMERVILLE, NJ), AND A DRAIN WAS PLACED IF NECESSARY. REPORTED COMPLICATIONS INCLUDE WITHOUT SURGICAL SUCCESS (N=42), SMALL SUPERFICIAL WOUND DEHISCENCE (N=1), AND GLOBUS SENSATION AND INTERMITTENT DYSPHAGIA (N=1). IN CONCLUSION, THE MAGNITUDE OF IMPROVEMENT IN POLYSOMNOGRAPHIC PARAMETERS AFTER HYOID SUSPENSION TO THYROID APPEARS TO BE MORE SIGNIFICANT IN PATIENTS WITH LOWER BMI. EVEN PATIENTS WITH AN OBESE BMI AND SEVERE OSA ACHIEVE SIGNIFICANT IMPROVEMENT FROM THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117373 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other