BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18788321 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-01957
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    April 25, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. H6 CLINICAL CODE: E2402 ¿ RESIDUAL SYMPTOMS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-01956 AND 2210968-2024-01957. CITATION: HERNIA (2020); HTTPS://DOI.ORG/10.1007/S10029-020-02188-5.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC POSTERIOR CRUROPLASTY: A PATIENT TAILORED APPROACH. THE PURPOSE OF THIS RETROSPECTIVE SINGLE-CENTER STUDY IS TO DESCRIBE A STANDARDIZED ¿PATIENT TAILORED¿ APPROACH FOR LAPAROSCOPIC POSTERIOR CRUROPLASTY IN THE SETTING OF ELECTIVE HIATAL HERNIA REPAIR. BETWEEN NOVEMBER 2015 TO NOVEMBER 2019, A TOTAL OF 141 PATIENTS (76 WERE FEMALES; MEAN AGE WAS 65.1 ± 13.7 YEARS) UNDERWENT LAPAROSCOPIC HIATUS HERNIA REPAIR AND TOUPET FUNDOPLICATION DURING THE STUDY PERIOD AND WERE MANAGED ACCORDING TO THE DESCRIBED ¿PATIENT TAILORED¿ CONCEPT. FOR SCORE <5, CRUROPLASTY WAS PERFORMED WITH INTERRUPTED NON-RESORBABLE SUTURES (PROLENE® 2.0-ETHICON). WHILE SCORE >5, CRUROPLASTY WAS PERFORMED WITH INTERRUPTED SUTURE REINFORCED WITH MESH (COMPETITOR) AND FIXED WITH TWO INTRACORPOREAL RESORBABLE BRAIDED SUTURES (VYCRIL® 2.0-ETHICON). OVERALL, 102 PATIENTS UNDERWENT SIMPLE SUTURE REPAIR WHILE SIMPLE SUTURE REPAIR BUTTRESSED WITH BIOSYNTHETIC RESORBABLE U SHAPED MESH [PHASIX ST ®-BARD] WAS USED IN 39 (27.7%) PATIENTS. TOUPET FUNDOPLICATION WAS FASHIONED IN ALL PATIENTS. REPORTED COMPLICATIONS INCLUDE HERNIA RECURRENCE (N=3), POSTOPERATIVE DYSPHAGIA (N=2), GAS BLOAT SYMPTOMS (N=31), RESIDUAL SYMPTOMS (N=11%), AND TRANSIENT GASTRIC DISTENSION (N=1). IN CONCLUSION, THE APPLICATION OF A STANDARDIZED ¿PATIENT TAILORED¿ CONCEPT FOR LAPAROSCOPIC POSTERIOR CRUROPLASTY SEEMS SAFE AND EFFECTIVE IN THE MEDIUM-TERM FOLLOW-UP WITH PROMISING PERIOPERATIVE OUTCOMES AND QUALITY OF LIFE IMPROVEMENT. THIS APPROACH MAY BE VALUABLE TO ASSURE PROCEDURE REPRODUCIBILITY, STANDARDIZATION, AND TO UNIFORMLY INTERPRET THE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111061 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention