BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 15330373 · Received August 31, 2022

    Report

    Report Number
    2210968-2022-07161
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    February 18, 2020
    Report Date
    August 31, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CLINICAL CODE: E2402 ¿ GERD NOT IMPROVED AFTER SURGERY. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1007/S00464-020-07430-W.

    Description of Event or Problem · 0

    TITLE: SINGLE ANASTOMOSIS SLEEVE ILEAL (SASI) BYPASS VERSUS SLEEVE GASTRECTOMY: A CASE-MATCHED MULTICENTER STUDY. THIS RETROSPECTIVE, CASE-MATCHED MULTI-CENTER STUDY AIMED TO COMPARE THE OUTCOME OF SINGLE ANASTOMOSIS SLEEVE ILEAL (SASI) BYPASS AND SLEEVE GASTRECTOMY (SG) IN REGARDS WEIGHT LOSS, IMPROVEMENT IN COMORBIDITIES AT 12 MONTHS OF FOLLOW-UP, AND POSTOPERATIVE COMPLICATIONS. BETWEEN JANUARY 2016 AND JULY 2018, A TOTAL OF 116 PATIENTS (19 MALE AND 97 FEMALE; MEAN AGE OF 35.8 ± 9.4 YEARS) WERE PROSPECTIVELY COLLECTED IN TWO ACADEMIC CENTERS; THE GENERAL SURGERY DEPARTMENT, MANSOURA UNIVERSITY HOSPITALS, EGYPT AND THE AL QASSIMI HOSPITAL, SHARJAH, UAE. 58 OF THESE PATIENTS (13 MALE AND 45 FEMALE; MEAN AGE OF 37.9 ± 8.5 YEARS; MEAN BMI OF 48.9 ± 16.9 KG/M2) WHO UNDERWENT SASI BYPASS WERE MATCHED WITH A SIMILAR NUMBER OF PATIENTS WHO UNDERWENT SG (N=58; 6 MALE AND 52 FEMALE; MEAN AGE OF 36.9 ± 9.8 YEARS; MEAN BMI OF 51.5 ± 25.9 KG/M2). IN SLEEVE GASTRECTOMY, HARMONIC ACE SCALPEL¿ WAS USED FOR DISSECTION OF THE GREATER CURVATURE STARTED 5 CM AWAY FROM THE PYLORUS UP TO THE CARDIO-ESOPHAGEAL JUNCTION. AFTERWARDS, A 36-FR BOUGIE WAS INSERTED INTO THE STOMACH AND THE STOMACH WAS THEN RESECTED USING LINEAR STAPLERS STARTING 5 CM FROM THE PYLORUS UP TO THE ANGLE OF HISS. IN SASI BYPASS, UPON COMPLETION OF SG AN CREATION OF THE GASTRIC TUBE, THE PATIENT¿S POSITION WAS CHANGED TO TRENDELENBURG POSITION. 250 CM OF ILEUM WERE MEASURED STARTING FROM THE ILEOCECAL JUNCTION. USING 45-MM LINEAR STAPLER, AN ANTECOLIC SIDE-TO SIDE ANASTOMOSIS BETWEEN THE ANTRUM OF THE STOMACH AND THE ILEUM WAS CREATED. THE ANTERIOR WALL OF GASTROENTEROSTOMY WAS CLOSED WITH A VICRYL OR V-LOCK 2/0 CONTINUOUS SUTURES. THE RESECTED STOMACH WAS REMOVED THROUGH THE LEFT MIDCLAVICULAR PORT AND A DRAIN WAS PLACED AND LEFT FOR 24 H. REPORTED COMPLICATIONS INCLUDE GERD NOT IMPROVED AFTER SURGERY (N=1), BLEEDING (N=1), AND BOWEL OBSTRUCTION (N=1). IN CONCLUSION, THE %EWL AT 12 MONTHS AFTER SASI BYPASS WAS SIGNIFICANTLY HIGHER THAN AFTER SG. SASI BYPASS CONFERRED BETTER IMPROVEMENT IN T2DM AND GERD THAN SG. BOTH PROCEDURES HAD SIMILAR WEIGHT LOSS AT 6 MONTHS POSTOPERATIVELY AND COMPARABLE COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469198 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other