BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8613006 · Received May 15, 2019

    Report

    Report Number
    3006722112-2019-00083
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    September 25, 2018
    Report Date
    October 2, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SHELL WAS NOTED TO BE DISCOLORED, AS IT WAS DARK BLUE AND GREEN IN APPEARANCE. WHITE PARTICLES AND YELLOW PARTICULATE MATTER WERE NOTED ON THE OUTER SURFACE OF THE BALLOON SHELL. 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 LEAKAGE WAS NOTED FROM SEVERAL OPENINGS ON THE BALLOON SHELL. UNDER MICROSCOPIC ANALYSIS, FOURTEEN OPENINGS WERE IDENTIFIED ON THE BALLOON SHELL; ONE OPENING WAS LOCATED ON THE ANTERIOR PORTION OF THE SHELL, AND THIRTEEN OPENINGS WERE LOCATED ON THE RADIUS OF THE SHELL. ALL FOURTEEN OPENINGS IN THE BALLOON SHELL WERE NOTED TO HAVE STRIATED EDGES, CONSISTENT WITH DAMAGE FROM A SURGICAL TOOL, AND SURGICAL DAMAGE FROM DEVICE REMOVAL ACTIVITIES. BROWN PARTICULATE MATTER WAS OBSERVED ON THE INNER SURFACE OF THE SLIT VALVE. DEVICE LABELING ADDRESSES THE REPORTED EVENT AS FOLLOWS: WARNINGS AND PRECAUTIONS: 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: SPONTANEOUS OVER INFLATION OF AN INDWELLING BALLOON WITH SYMPTOMS INCLUDING INTENSE ABDOMINAL PAIN, SWELLING OF THE ABDOMEN (ABDOMINAL DISTENSION) WITH OR WITHOUT DISCOMFORT, DIFFICULTY BREATHING, AND/OR VOMITING. PATIENTS EXPERIENCING ANY OF THESE SYMPTOMS SHOULD BE COUNSELED TO SEEK IMMEDIATE CARE.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA365 INTRAGASTRIC BALLOON HAD "AXR DONE AS PART OF ROUTINE CHECKS. AIR IN BALLOON NOTED. HYPERINFLATION." THE PATIENT REPORTED HAIR LOSS. THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406130 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01618

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR