BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 22059568 · Received May 21, 2025

    Report

    Report Number
    2210968-2025-05636
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    June 26, 2024
    Report Date
    May 21, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: GLAND SURG. 2024 JUN 30;13(6):852-863. HTTPS://DOI.ORG/10.21037/GS-24-45. EPUB 2024 JUN 26. PMID: 39015706; PMCID: PMC11247577.

    Description of Event or Problem · 0

    TITLE: COMPARING OUTCOMES OF PREPECTORAL, PARTIAL MUSCLE-SPLITTING SUBPECTORAL, AND DUAL-PLANE SUBPECTORAL DIRECT-TO-IMPLANT RECONSTRUCTION: IMPLANT UPWARD MIGRATION AND THE PECTORALIS MUSCLE. THIS STUDY AIMS TO COMPARE THE INCIDENCE OF COMPLICATIONS SUCH AS RIPPLING, ANIMATION DEFORMITY, IMPLANT UPWARD MIGRATION BETWEEN THE DUAL-PLANE, THE PARTIAL MUSCLE SPLITTING SUBPECTORAL AND THE PREPECTORAL RECONSTRUCTION GROUP. IN ADDITION, MULTIVARIATE ANALYSIS WAS CONDUCTED TO IDENTIFY THE RISK FACTORS OF COMPLICATIONS. RETROSPECTIVELY 349 PATIENTS WERE INVESTIGATED WHO UNDERWENT DIRECT-TO-IMPLANT BREAST RECONSTRUCTION FROM JANUARY 2017 TO OCTOBER 2020. THE VICRYL PLUS 2-0 (ETH) WAS USED FOR IMF REPAIR AND WAS PERFORMED BEFORE IMPLANT INSERTION. IT WAS ALSO USED TO SUTURED THE ADM. REPORTED COMPLICATIONS: VICRYL PLUS 2-0 SIGNIFICANT ANIMATION DEFORMITY (N=5) TREATMENT: NOT PROVIDED BREAST PAIN (N=21) TREATMENT: NOT REPORTED CAPSULAR CONTRACTURE (N=14) TREATMENT: NOT REPORTED SEROMA (N=50) TREATMENT: NOT REPORTED RIPPLING (N=90) TREATMENT: NOT REPORTED NOTICEABLE UPPER POLE IMPLANT EDGE (N=11) TREATMENT: NOT REPORTED IMPLANT UPWARD MIGRATION (N=42) TREATMENT: NOT REPORTED IN CONCLUSION, PREPECTORAL AND PARTIAL MUSCLE-SPLITTING SUBPECTORAL RECONSTRUCTION ARE ASSOCIATED WITH A LOWER INCIDENCE OF SEROMA FORMATION, BREAST PAIN, ANIMATION DEFORMITY, AND UPWARD MIGRATION OF THE IMPLANT THAN DUAL-PLANE SUBPECTORAL RECONSTRUCTION. P0 AND P1 SHOWED BETTER POSTOPERATIVE OUTCOMES THAN P2. ADDITIONALLY, P0 HAD LESS IMPLANT MIGRATION THAN P1. EVEN THOUGH P1 MINIMALLY DISSECTS THE MUSCLE, THE LOCATION OF THE IMPLANT MAY CHANGE. CONSIDERING THAT MUSCLE CONTRACTION CAN DETERIORATE SYMMETRY AND AESTHETIC RESULTS, THE P0 METHOD MAY BE THE MOST FAVORABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72949 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other