BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ENDO EGIA SULU

    MDR report key: 8803232 · Received July 18, 2019

    Report

    Report Number
    1219930-2019-04213
    Event Type
    Death
    Date Received
    July 18, 2019
    Date of Event
    September 30, 2018
    Report Date
    July 18, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: OUTCOMES OF ROUX-EN-Y GASTRIC BYPASS VERSUS SLEEVE GASTRECTOMY IN SUPER-SUPER-OBESE PATIENTS (BMI =60 KG/M2): 6-YEAR FOLLOW-UP AT A SINGLE UNIVERSITY. SOURCE: SURGERY FOR OBESITY AND RELATED DISEASES VOLUME 15, 2019 (23-35). DATE OF PUBLICATION: 30 SEPTEMBER 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE, A STUDY WAS CONDUCTED ON 210 PATIENTS FROM JANUARY 2000 THROUGH DECEMBER 2011 WITH MULTIPLE COMORBIDITIES TO COMPARE THE LONG-TERM OUTCOMES BETWEEN A LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) AND A LAPAROSCOPIC ROUX-EN-Y BYPASS (RYGB) AND ALSO TO EVALUATE THE EFFICACY OF LSG AS A STAND-ALONG BARIATRIC PROCEDURE FOR SUPER-SUPER OBESE (SSO) PATIENTS. THE ARTICLE DISCUSSES VARIOUS SHORT AND/OR LONG-TERM ADVERSE EVENTS WITH DIFFERENT RESOLUTIONS AND TREATMENTS IN RELATION TO EACH PATIENT. OF THESE ADVERSE EVENTS, 2 PATIENTS REPORTEDLY DIED WITHIN THE FIRST 30 DAYS POST-OPERATIVELY. ONE PATIENT IN THE RYGB GROUP DIED FROM SEPTIC SHOCK AND 1 PATIENT IN THE LSG GROUP DIED FROM CARDIAC ARREST AT THE END OF THE INTERVENTION. THE AUTHORS CONCLUDE THOUGH THAT ¿LSG AS A PRIMARY PROCEDURE FOR SSO PATIENTS REMAINS EFFECTIVE EVEN THOUGH RYGB ACHIEVES BETTER MIDTERM OUTCOMES. LSG CAN BE PROPOSED AS THE PRIMARY-OPTION PROCEDURE. FURTHER INVESTIGATIONS ARE NEEDED TO IDENTIFY THE IDEAL PROCEDURE FOR PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE. DEATH NOT RELATED TO DEVICE: SEPTIC SHOCK & CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596149 UNKNOWN ENDO EGIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO EGIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death