BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9965033 · Received April 15, 2020

    Report

    Report Number
    2210968-2020-03063
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    March 20, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ATTEMPTS HAVE 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED? PATIENT DEMOGRAPHICS? CITATION: OBES SURG (2018) 28:636¿642 / DOI 10.1007/S11695-017-2904-2. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: INCREASED METABOLIC BENEFIT FOR OBESE, ELDERLY PATIENTS UNDERGOING ROUX-EN-Y GASTRIC BYPASS VS SLEEVE GASTRECTOMY " AUTHOR(S): KATHERINE D. GRAY & MAUREEN D. MOORE & OMAR BELLORIN & JONATHAN S. ABELSON & GREGORY DAKIN & RASA ZARNEGAR & ALFONS POMP & CHEGUEVARA AFANEH. CITATION: OBES SURG (2018) 28:636¿642 / DOI 10.1007/S11695-017-2904-2. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS (LRYGB) AND LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IN AN ELDERLY POPULATION AND COMPARE THE METABOLIC BENEFIT BETWEEN THE TWO PROCEDURES TO DETERMINE OPTIMAL PROCEDURE SELECTION IN THIS HIGH-RISK COHORT. BETWEEN SEPTEMBER 2007 AND DECEMBER 2014, A TOTAL OF 134 PATIENTS (N=55 MALE, N=79 FEMALE, MEAN AGE 64 YEARS (60¿75 YEARS), MEAN BMI 44.0 ± 6.1 KG/M2) UNDERWENT BARIATRIC SURGERY. THE PATIENTS HAD EITHER LSG [N=65 (N=23 MALE, N=42 FEMALE, MEAN AGE 65 YEARS (60¿74 YEARS), MEAN BMI 44.4 ± 6.3 KG/M2)] OR LRYGB [N=69 (N=32 MALE, N=37 FEMALE, MEAN AGE 63 YEARS (60¿75 YEARS), MEAN BMI 43.6 ± 5.9 KG/M)]. FOR LSG GROUP, A 40-FR BOUGIE WAS PLACED BY ANESTHESIA TO GUIDE RESECTION, AND THE STAPLE LINE IS BUTTRESSED WITH OMENTUM USING 2¿0 VICRYL SUTURE (ETHICON). POSTOPERATIVE COMPLICATIONS INCLUDED HEMORRHAGE (N=2) WITH TRANSFUSION; AND INFECTIOUS (N=3). BOTH LSG AND RYGB CAN BE SAFELY PERFORMED ON MORBIDLY OBESE, ELDERLY ADULTS. AT INTERMEDIATE FOLLOW-UP, THERE IS AN INCREASED METABOLIC BENEFIT FOR ELDERLY PATIENTS UNDERGOING LRYGB OVER LSG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425901 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention