BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8613041 · Received May 15, 2019

    Report

    Report Number
    3006722112-2019-00080
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    May 31, 2018
    Report Date
    September 13, 2019
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: A VISUAL EXAMINATION WAS PERFORMED ON THE DEVICE, AND NOTED THE DEVICE WAS RETURNED DEPLOYED. THE BALLOON WAS NOTED TO BE DISCOLORED, AS THE SHELL AND CENTER PATCH WERE LIGHT GREEN IN APPEARANCE. BLUE PARTICLES WERE OBSERVED ON THE INNER SURFACE OF THE VALVE CHANNEL. A VALVE TEST WAS PERFORMED AND THE FLOW OF DI WATER WAS CONTINUOUS AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED AND THE BALLOON WAS LEAKING FROM ONE SMALL OPENING ON THE ANTERIOR PORTION OF THE BALLOON SHELL NEAR THE CENTER PATCH, AND TWO SMALL OPENINGS ON THE POSTERIOR PORTION OF THE BALLOON SHELL. UNDER MICROSCOPIC ANALYSIS, IT WAS OBSERVED THAT THERE WAS ONE SMALL OPENING ON THE ANTERIOR PORTION NEAR THE CENTER PATCH. THE EDGES WERE NOTED TO BE STRIATED, AND WAS CONSISTENT WITH SURGICAL DAMAGE. TWO SMALL OPENINGS WERE OBSERVED ON THE POSTERIOR PORTION OF THE BALLOON SHELL. BOTH OPENINGS WERE NOTED TO HAVE STRIATIONS, AND ARE CONSISTENT WITH SURGICAL DAMAGE FROM DEVICE REMOVAL ACTIVITIES. BROWN PARTICULATE MATTER WAS OBSERVED ON THE INNER SURFACE OF THE VALVE CHANNEL.

    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 REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: 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 ORBERA365 INTRAGASTRIC BALLOON HAD EXPERIENCED BALLOON LEAK. DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406758 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01242

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR