BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 9105428 · Received September 23, 2019

    Report

    Report Number
    3006722112-2019-00095
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    November 14, 2018
    Report Date
    January 24, 2019
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO APOLLO, AND A VISUAL INSPECTION WAS PERFORMED. THE BALLOON WAS NOTED TO BE DISCOLORED, AS THE SHELL WAS DARK GREEN IN APPEARANCE, AND THE CENTER PATCH WAS LIGHT BROWN IN APPEARANCE. GREEN, WHITE, AND YELLOW PARTICLES WERE OBSERVED ON THE INNER AND OUTER SURFACES OF THE BALLOON SHELL. A VALVE TEST WAS PERFORMED, AND WHEN DI WATER WAS INJECTED, THE FLOW OF FLUID WAS CONTINUOUS AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED, AND THE BALLOON WAS NOTED TO BE LEAKING FROM THE TEAR ON THE POSTERIOR PORTION OF THE SHELL, IN ADDITION TO FOUR OPENINGS ON THE ANTERIOR PORTION OF THE SHELL, NEAR THE CENTER PATCH. UNDER MICROSCOPIC ANALYSIS, ALL FOUR OPENINGS ON THE ANTERIOR PORTION OF THE SHELL WERE NOTED TO HAVE STRIATED EDGES, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL. UNDER MICROSCOPIC ANALYSIS, THE APPARENT ORIGINATION POINT OF THE LARGE TEAR WAS NOTED TO BE STRIATED, AND CONSISTENT WITH DEVICE REMOVAL ACTIVITIES. BROWN PARTICLES WERE OBSERVED ON THE INNER SURFACE OF THE SLIT VALVE. A REVIEW OF THE DEVICE LABELING NOTED 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 HAD "....URINE BLUE...." INFORMATION RECEIVED VIA SPAIN REGULATORY (AEMPS): "SPONTANEOUS RUPTURE OF A 12 MONTHS INTRAGASTRIC BALLOON AT MONTH 7. BALLOON IMPLANTED IN A PATIENT, ACCORDING TO OUR USUAL PROTOCOL, WHICH HAS BEEN MAINTAINED SINCE 2006 (THE SAME HUMAN AND TECHNICAL TEAM). THE SILICONE INTRAGASTRIC BALLOONS ARE FILLED WITH PHYSIOLOGICAL SERUM AND 10 CC OF METHYLENE BLUE. SEVEN MONTHS AFTER THE IMPLANTATION, THE PATIENT WARNED US AT OUR EMERGENCY PHONE NUMBER, FOR HAVING URINATED GREENISH - BLUE, ON SUSPICION OF SPONTANEOUS BREAK OF THE BALLOON DURING THE NIGHT. PREFERENTIAL REVISION ENDOSCOPY HAS BEEN SCHEDULED FOR THE NEXT DAY, FINDING THE INTRAGASTRIC BALLOON PARTIALLY EMPTY AND BROKEN OR OPEN ON ONE OF ITS SIDES. IT IS EXTRACTED WITHOUT INCIDENTS. THE BALLOON HAS BEEN DELIVERED TO THE DISTRIBUTION COMPANY, PROOF OF DELIVERY WAS GIVEN TO THE RESPONSIBLE PERSON. SUBSEQUENT CLINICAL EVOLUTION OF THE PATIENT: NORMAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900830 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01608

    Patients

    Seq Age Sex Outcome Treatment
    1