BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 5474189 · Received March 2, 2016

    Report

    Report Number
    3006722112-2016-00034
    Event Type
    Death
    Date Received
    March 2, 2016
    Date of Event
    January 29, 2016
    Report Date
    February 2, 2016
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 03/02/2016 FURTHER INFORMATION HAS BEEN REQUESTED OF THE INITIAL REPORTER, INCLUDING PATIENT HISTORY AND IF A COPY OF THE AUTOPSY REPORT OR ANY OTHER LAB TESTS ARE AVAILABLE. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY APOLLO 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). 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, 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. COMPLICATIONS OF ROUTINE ENDOSCOPY INCLUDE: CARDIAC OR RESPIRATORY ARREST (THESE ARE EXTREMELY RARE AND ARE USUALLY RELATED TO SEVERE UNDERLYING MEDICAL PROBLEMS).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE RECEIVED A NOTIFICATION FROM A PHYSICIAN REPORTING: A PATIENT HAD THE ORBERA INTRAGASTRIC BALLOON PLACED, "WHO PROGRESSED WELL IN THE FIRST DAYS BUT DIED IN THE 10TH DAY. THE PATIENT HAD A HEART ATTACK AND THE AUTOPSY REPORT WAS NOT CONCLUSIVE." APOLLO'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBTS IN FAVOR OF REPORTING. AS THE EVENT OCCURRED SO CLOSELY TO THE IMPLANT DATE, AND THE AUTOPSY RESULTS ARE INCONCLUSIVE, APOLLO WILL REPORT THIS EVENT TO THE FDA. THERE IS NO EVIDENCE AT THIS TIME OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129462 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. N/A 2744814

    Patients

    Seq Age Sex Outcome Treatment
    1 Death