BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8606102 · Received May 13, 2019

    Report

    Report Number
    3006722112-2019-00099
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 18, 2019
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THIS LATE MEDWATCH REPORT: "DURING A FEBRUARY 2019 INTERNAL REVIEW OF POST-MARKET SURVEILLANCE DATA FOR ALL APOLLO PRODUCTS, APOLLO EXECUTIVE MANAGEMENT WAS MADE AWARE THAT COMPLAINTS ASSOCIATED WITH THE CE MARKED ORBERA365 (12-MONTH INTRAGASTRIC BALLOON) WERE NOT BEING ASSESSED FOR REPORTABILITY CONSISTENT WITH THE REQUIREMENTS OF 21 CFR 803. CONSIDERATION FOR REPORTABILITY IN THE US WAS INCORRECTLY ESTABLISHED BASED ON THE DIFFERENCE IN THE INDICATIONS FOR USE (I.E. 12-MONTH PLACEMENT VS 6-MONTH PLACEMENT) VS CONSIDERATIONS FOR SIMILAR DEVICES MARKETED BY APOLLO. THE ORBERA365 12-MONTH INTRAGASTRIC BALLOON IS A SIMILAR DEVICE AS COMPARED TO THE ORBERA 6-MONTH BALLOON APPROVED VIA PMA P140008, AND AS SUCH, COMPLAINTS WILL BE ASSESSED FOR MDR REPORTABILITY GOING FORWARD." THE PHYSICIAN INDICATED THE DEVICE WAS DISCARDED AND WOULD NOT BE RETURNED FOR ANALYSIS. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: WARNINGS AND PRECAUTIONS: THE RISK OF BALLOON DEFLATION AND INTESTINAL OBSTRUCTION (AND THEREFORE POSSIBLE DEATH RELATED TO INTESTINAL OBSTRUCTION) MAY BE HIGHER WHEN BALLOONS ARE LEFT IN PLACE LONGER THAN 12 MONTHS OR USED AT LARGER VOLUMES (GREATER THAN 700 CC). THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF THE ORBERA365¿ 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 ORBERA365¿ SYSTEM INCLUDE: BALLOON DEFLATION AND SUBSEQUENT REPLACEMENT.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA365 INTRAGASTRIC BALLOON HAD NOTED "THE BALLOON WAS DEFLATED THE DAY OF EXPLANTING, THAT IS 1 YEAR AFTER IT WAS PLACED, AS PLANNED." ADDITIONAL INFORMATION NOTED, "FOLLOWING EXCISION OF ORBERA GASTRIC BALLOON AFTER ONE YEAR, FINDING THAT IT WAS TORN ON 5 CM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397424 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01432

    Patients

    Seq Age Sex Outcome Treatment
    1