BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19054626 · Received April 5, 2024

    Report

    Report Number
    2210968-2024-03947
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    August 17, 2020
    Report Date
    April 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: PHARYNGOCUTANEOUS FISTULA, 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: INDIAN J OTOLARYNGOL HEAD NECK SURG (OCTOBER 2022); 74(SUPPL 2):S2139¿S2148. HTTPS://DOI.ORG/10.1007/S12070-020-02046-X 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: PHARYNGOCUTANEOUS FISTULA FOLLOWING PRIMARY AND SALVAGE LARYNGECTOMY: AETIOLOGY AND PREDICTIVE FACTORS THIS RETROSPECTIVE STUDY WITH PROSPECTIVE ANALYSIS AIMED TO STUDY THE FACTORS BEFORE AND AT THE SURGERY THAT ARE ASSOCIATED WITH PCF FORMATION IN A SOUTH INDIAN TERTIARY CARE HOSPITAL. BETWEEN MAY 2014 AND APRIL 2019, A TOTAL OF 112 PATIENTS [103 MALE AND 9 FEMALE; MEAN AGE OF 58.07 YEARS (RANGE, 30¿86 YEARS)] DIAGNOSED WITH LARYNGEAL OR HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA WHO UNDERWENT A PRIMARY OR SALVAGE TOTAL LARYNGECTOMY (TL) WERE INCLUDED IN THE STUDY. PRIMARY PHARYNGEAL RECONSTRUCTION WAS PERFORMED IN TWO LAYERS, MUCOSAL AND MUSCULAR, CLOSURE OF THE PHARYNX WAS CARRIED OUT IN A VERTICAL MANNER, MUCOSA INVERTING WITH A CONTINUOUS ALTERNATE INTERLOCKING TECHNIQUE USING VICRYL (POLYGLACTIN) SUTURES. REPORTED COMPLICATIONS INCLUDE PHARYNGOCUTANEOUS FISTULA (N=18). IN CONCLUSION, HYPOPHARYNGEAL PRIMARY TUMOR, HISTOLOGICAL MARGIN POSITIVITY, ABSENCE OF PRIOR TRACHEOSTOMY AND EXTENSION OF TUMOR IN PYRIFORM SINUS MUCOSA ARE SIGNIFICANT RISK FACTORS OF PCF FORMATION. PRIOR RADIOTHERAPY SHOWED A STRONG CLINICAL SIGNIFICANCE EVEN THOUGH IT IS STATISTICALLY INSIGNIFICANT. MOST PCF HEAL BY CONSERVATIVE MANAGEMENT AND VASCULARISED MUSCLE FLAP HAS A PROMISING ROLE IN PREVENTING THE PCF FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758199 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention