BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16596991 · Received March 23, 2023

    Report

    Report Number
    2210968-2023-01965
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    September 22, 2021
    Report Date
    March 23, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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/DEATH 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? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. 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 2210968-2023-01965, 2210968-2023-01966, 2210968-2023-01967. CITATION: J. CLIN. MED. 2021;10 (4291):1-8. HTTPS://DOI.ORG/10.3390/JCM10194291.

    Description of Event or Problem · 0

    TITLE: EXPERIENCE WITH A HYBRID PROCEDURE INVOLVING LAPAROSCOPIC FUNDOPLICATION WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY IN CHRONICALLY ILL CHILDREN. THIS STUDY COMPARES THE OUTCOMES BETWEEN PATIENTS WHO RECEIVED LNF WITH LG AND THOSE WHO RECEIVED LNF WITH PEG. BETWEEN MARCH 2012 AND NOVEMBER 2019, 63 PATIENTS (33 MALE AND 30 FEMALE) AGED <18 YEARS WHO UNDERWENT LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF) AND GASTROSTOMY WITH EITHER LAPAROSCOPIC GASTROSTOMY (LG) OR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WERE INCLUDED IN THE STUDY. AMONG THESE, 14 PATIENTS (9 MALE AND 5 FEMALE) UNDERWENT LG, AND 49 PATIENTS (24 MALE AND 25 FEMALE) UNDERWENT PEG. THE MEDIAN (RANGE) AGES AND BODY WEIGHTS OF PATIENTS WERE 4.25 (0.68¿18.26) YEARS AND 14.15 (3.9¿25.7) KG AND 2.58 (0.21¿16.4) YEARS AND 10.60 (4.84¿46.5) KG IN THE LG AND PEG GROUPS, RESPECTIVELY. DURING LNF, AFTER PEELING THE SHORT GASTRIC ARTERIES, THE FUNDUS AROUND THE GASTROESOPHAGEAL JUNCTION IS WRAPPED AND FIXED WITH AN INTERRUPTED SUTURE USING AN ETHIBOND 4¿0. IN THE SURGICAL GASTROSTOMY GROUP, AFTER LNF, A SMALL STAB INCISION FOR GASTROSTOMY WAS MADE FOR DELIVERY OUT OF THE STOMACH THROUGH THIS SITE, AND GASTROSTOMY WAS PERFORMED. A HIGH-PROFILE BALLOONED GASTROSTOMY TUBE (MIC, KIMBERLY-CLARK) WAS INSERTED, AND A PURSE-STRING SUTURE WITH VICRYL 4¿0 WAS APPLIED AROUND THE GASTROSTOMY SITE. REPORTED COMPLICATIONS INCLUDE: IN THE LG GROUP, LOCAL INFLAMMATION AT THE GASTROSTOMY SITE (N=1), PERITONITIS (N=1), PERFORATION (N=1), AND RECURRENT GASTROESOPHAGEAL REFLUX (N=1) AND REQUIRED ANOTHER LAPAROSCOPIC NISSEN FUNDOPLICATION. IN THE PEG GROUP, PERITONITIS (N=1) AND DEATH OF A 7-MONTH-OLD FEMALE (N=1) DUE TO KLEBSIELLA PNEUMONIAE SEPSIS ON THE SIXTH POSTOPERATIVE DAY. IN CONCLUSION, THIS PROCEDURE SHOWS A SIGNIFICANTLY SHORTER OPERATION TIME THAN CONVENTIONAL SURGICAL GASTROSTOMY. ADDITIONALLY, ENDOSCOPY HAS THE ADVANTAGE OF VISUALLY CONFIRMING FUNDOPLICATION. THEREFORE, WE CONCLUDE THAT LNF COMBINED WITH PEG IS A SUPERIOR METHOD FOR PERFORMING GASTROSTOMY THAN LG IN CHRONICALLY ILL CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480757 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other