BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8613834 · Received May 15, 2019

    Report

    Report Number
    3006722112-2019-00081
    Event Type
    Death
    Date Received
    May 15, 2019
    Date of Event
    April 19, 2019
    Report Date
    April 19, 2019
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION HAS BEEN REQUESTED OF THE INITIAL REPORTER REGARDING: AUTOPSY REPORT WHEN AVAILABLE, DEVICE INFORMATION, AND PATIENT INFORMATION. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY APOLLO. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: INDICATIONS FOR USE: EACH PHYSICIAN AND PATIENT SHOULD EVALUATE THE RISKS ASSOCIATED WITH ENDOSCOPY AND INTRAGASTRIC BALLOONS (SEE COMPLICATIONS BELOW) AND THE POSSIBLE BENEFITS OF A TEMPORARY TREATMENT FOR WEIGHT LOSS PRIOR TO USE OF THE ORBERA® SYSTEM. CONTRAINDICATIONS FOR USE OF ORBERA: ANY OTHER MEDICAL CONDITION WHICH WOULD NOT PERMIT ELECTIVE ENDOSCOPY. COMPLICATIONS OF ROUTINE ENDOSCOPY INCLUDE: CARDIAC OR RESPIRATORY ARREST (THESE ARE EXTREMELY RARE AND ARE USUALLY RELATED TO SEVERE UNDERLYING MEDICAL PROBLEMS). WARNINGS AND PRECAUTIONS: THE RISK OF BALLOON DEFLATION AND INTESTINAL OBSTRUCTION (AND THEREFORE POSSIBLE DEATH RELATED TO INTESTINAL OBSTRUCTION) IS SIGNIFICANTLY HIGHER WHEN BALLOONS ARE LEFT IN PLACE LONGER THAN 6 MONTHS OR USED AT LARGER VOLUMES (GREATER THAN 700 CC). BOWEL OBSTRUCTIONS HAVE BEEN REPORTED DUE TO DEFLATED BALLOONS PASSING INTO THE INTESTINES AND HAVE REQUIRED SURGICAL REMOVAL. SOME OBSTRUCTIONS HAVE REPORTEDLY BEEN ASSOCIATED WITH PATIENTS WHO HAVE DIABETES OR WHO HAVE HAD PRIOR ABDOMINAL SURGERY, SO THIS SHOULD BE CONSIDERED IN ASSESSING THE RISK OF THE PROCEDURE. BOWEL OBSTRUCTIONS CAN RESULT IN DEATH. THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF THE ORBERA® SYSTEM BALLOON MAY VARY DEPENDING UPON THE PATIENT'S GENERAL CONDITION AND THE LEVEL AND TYPE OF ACTIVITY. THE TYPES AND FREQUENCY OF ADMINISTRATION OF DRUGS OR DIET SUPPLEMENTS AND THE OVERALL DIET OF THE PATIENT MAY ALSO AFFECT THE RESPONSE. EACH PATIENT MUST BE MONITORED CLOSELY DURING THE ENTIRE TERM OF TREATMENT IN ORDER TO DETECT THE DEVELOPMENT OF POSSIBLE COMPLICATIONS. EACH PATIENT SHOULD BE INSTRUCTED REGARDING SYMPTOMS OF DEFLATION, GASTROINTESTINAL OBSTRUCTION, ACUTE PANCREATITIS, SPONTANEOUS INFLATION, ULCERATION AND OTHER COMPLICATIONS WHICH MIGHT OCCUR, AND SHOULD BE ADVISED TO CONTACT HIS/HER PHYSICIAN IMMEDIATELY UPON THE ONSET OF SUCH SYMPTOMS. COMPLICATIONS: POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA® SYSTEM INCLUDE: DEATH DUE TO COMPLICATIONS RELATED TO INTESTINAL OBSTRUCTION IS POSSIBLE.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA INTRAGASTRIC BALLOON "WAS FOUND TO HAVE CARDIAC ARREST THIS AFTERNOON, FAILED CPR AND CERTIFIED." PATIENT WAS NOTED TO HAVE NO HISTORY OF HEART DISEASE. IT IS UNKNOWN IF AN AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407449 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death