BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 9098983 · Received September 20, 2019

    Report

    Report Number
    3006722112-2019-00079
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    February 15, 2018
    Report Date
    April 16, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    APOLLO HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. 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. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: 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, 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: GASTRIC DISCOMFORT, FEELINGS OF NAUSEA AND VOMITING FOLLOWING BALLOON PLACEMENT AS THE DIGESTIVE SYSTEM ADJUSTS TO THE PRESENCE OF THE BALLOON. CONTINUING NAUSEA AND VOMITING. THIS COULD RESULT FROM DIRECT IRRITATION OF THE LINING OF THE STOMACH OR AS A RESULT OF THE BALLOON BLOCKING THE OUTLET OF THE STOMACH. IT IS EVEN THEORETICALLY POSSIBLE THAT THE BALLOON COULD PREVENT VOMITING (NOT NAUSEA OR RETCHING) BY BLOCKING THE INLET TO THE STOMACH FROM THE ESOPHAGUS.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA365 INTRAGASTRIC BALLOON PRESENTED WITH SYMPTOMS APPROXIMATELY A MONTH AFTER INSERTION. THE PATIENT WAS CONSTANTLY VOMITING, HAIR WAS GETTING THIN AND STARTED FALLING OUT, INFLAMED JOINTS. THE DEVICE WAS REMOVED THREE MONTHS POST PLACEMENT. THE PATIENT HAS REPORTED THAT SINCE HAVING THE DEVICE REMOVED THE PATIENT IS VERY WEAK, CAN'T WALK, IN PAIN AND PATIENT CANNOT USE HER ARM. THE PATIENT REPORTS THAT LOSS OF TOTAL USE IN RIGHT ARM HAS OCCURRED AND THE LEFT ARM IS STARTING TO ACHE. THE PATIENT WAS IN INTENSIVE CARE A WEEK POST DEVICE REMOVAL WITH A SUSPECTED STROKE FOR TWO DAYS. THE PATIENT IS HAVING DIFFICULTY SLEEPING DUE TO THE PAIN, HAS REPORTED HAVING A STIFF NECK AND PAIN IN THE KNEES. IT IS NOTED THAT THE PATIENT IS TRYING HOLISTIC MASSAGE TO ASSIST WITH THE SYMPTOMS. PER PHYSICIAN: REMOVED THE ORBERA DUE TO INTOLERANCE; NAUSEA AND VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890537 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01245

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention