BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 9100916 · Received September 20, 2019

    Report

    Report Number
    3006722112-2019-00092
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    July 1, 2018
    Report Date
    December 18, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    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. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO, AND A VISUAL INSPECTION WAS PERFORMED. THE BALLOON SHELL WAS NOTED TO BE DISCOLORED, AS IT WAS DARK GREEN IN APPEARANCE. THE CENTER PATCH WAS NOTED TO BE DISCOLORED, AS IT WAS YELLOW IN APPEARANCE. GREEN PARTICLES WERE NOTED ON THE OUTER SURFACE OF THE CENTER PATCH. A VALVE TEST WAS PERFORMED, AND WHEN DI WATER WAS INJECTED INTO THE BALLOON VALVE THE FLOW OF FLUID WAS CONTINUOUS AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED, AND THE BALLOON WAS NOTED TO BE LEAKING FROM SEVERAL OPENINGS. UNDER MICROSCOPIC ANALYSIS, SIX OPENINGS WERE OBSERVED: ONE OPENING WAS LOCATED ON THE ANTERIOR PORTION OF THE BALLOON SHELL, AND FIVE OPENINGS WERE LOCATED ON THE RADIUS OF THE SHELL. ALL SIX OPENINGS ON THE BALLOON SHELL WERE OBSERVED TO HAVE STRIATED EDGES, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL. A SMALL PORTION OF THE SHELL WAS NOTED TO BE MISSING FROM THE OPENING ON THE ANTERIOR PORTION OF THE SHELL. YELLOW PARTICULATE MATTER WAS NOTED ON THE INNER SURFACE OF THE VALVE CHANNEL. SEVERAL NON-PENETRATING NICKS/MARKS WERE NOTED ON THE BALLOON SHELL. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: WARNINGS AND PRECAUTIONS: DEFLATED DEVICES SHOULD BE REMOVED PROMPTLY. 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. IF IT IS NECESSARY TO REPLACE A BALLOON WHICH HAS SPONTANEOUSLY DEFLATED, THE RECOMMENDED INITIAL FILL VOLUME OF THE REPLACEMENT BALLOON IS THE SAME AS FOR THE FIRST BALLOON OR THE MOST RECENT VOLUME OF THE REMOVED BALLOON. A GREATER INITIAL FILL VOLUME IN THE REPLACEMENT BALLOON MAY RESULT IN SEVERE NAUSEA, VOMITING OR ULCER FORMATION. 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 ORBERA INTRAGASTRIC BALLOON COME IN "FOR REMOVAL OF THE BALLOON AFTER 13 MONTHS. [PATIENT] TELLS THAT SINCE JULY, [THEY] COULD NOT FEEL THE BALLOON. THE SURGEON MAKES A GASTROSCOPY TO REMOVE THE BALLOON AND FINDS THE BALLOON TOTALLY DEFLATED. THE BALLOON WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893752 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01246

    Patients

    Seq Age Sex Outcome Treatment
    1