BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 6171706 · Received December 13, 2016

    Report

    Report Number
    3006722112-2016-00369
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 10, 2016
    Report Date
    March 1, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA 01/26/2017. THE DEVICE WAS RETURNED TO APOLLO. A VISUAL EXAMINATION WAS PERFORMED, AND NOTED THE RETURNED DEVICE TO BE DISCOLORED, AND THE SHELL WAS DARK BROWN IN COLOR. (B)(6) FLUID WAS NOTED ON THE OUTER AND INNER SURFACES OF THE DEVICE. BROWN PARTICLES WERE NOTED ON THE OUTER SURFACE OF THE DEVICE. A VALVE TEST WAS PERFORMED AND THE FLOW OF DI WATER WAS CONTINUES AND UNOBSTRUCTED. AN AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS NOTED FROM A SINGLE OPENING ON THE SHELL. THE OPENINGS WERE NOTED TO BE STRIATED, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL. UNDER MICROSCOPIC AND VISUAL ANALYSIS, THE SHELL APPEARED TO BE DEGRADED (B)(6) AND (B)(6) PARTICLES WERE NOTED COVERING APPROXIMATELY 85% OF THE OUTER SURFACE OF THE SHELL AND ON THE VALVE PATCH.

    Additional Manufacturer Narrative · 1

    SUPPLEMENT #2 - MEDWATCH SENT TO THE FDA ON 26-JUL-2017. DEVICE EVALUATION SUMMARY: ADDITIONAL TESTING WAS PERFORMED ON THE DEVICE. FOREIGN MATTER WAS NOTED IN THE VALVE CHAMBER. THE BALLOON AND VALVE SURFACE WERE COVERED WITH BIOFILM. THE SLIT VALVE WAS REMOVED FROM THE DEVICE USING A RAZOR BLADE FOR TESTING. PRESSURE TESTING OF THE SLIT VALVE WAS PERFORMED, THE OUTSIDE TO INSIDE PRESSURE WAS NOTED TO BE 1.66 PSI. THE INSIDE TO OUTSIDE PRESSURE WAS NOTED TO BE 10 PSI. THE VALVE WAS CROSS-SECTIONED ALONG THE SEALING MECHANISM, AND EXAMINED MICROSCOPICALLY WITH A MAGNIFICATION BETWEEN 20X-60X. THE SURFACE OF SEALING MECHANISM SHOWED TYPICAL AXIAL LINES PARALLEL TO THE VALVE ACCESS DUE TO THE BLADE CUTTING DIRECTION DURING VALVE MANUFACTURING. THE INNER EDGE OF THE CUT APPEARED TO BE MORE DEFINED THAN THE OPPOSITE EDGE, LIKELY A CONSEQUENCE OF THE VALVE SLITTING PROCESS.

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON 12/13/2016. 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 EVENTS AS FOLLOWS: 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: -GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. - ABDOMINAL OR BACK PAIN, EITHER STEADY OR CYCLIC.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH ORBERA INTRAGASTRIC BALLOON STARTED "COMPLAINING ABOUT PAIN AND ABDOMINAL DEFORMITY. X-RAY AND PHYSICAL EXAM CONFIRMED HYPERINFLATED BALLOON". DEVICE HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822735 ORBERA INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50000 2747840

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention LOSARTAN| OMPRAZOL