BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8689488 · Received June 11, 2019

    Report

    Report Number
    3006722112-2019-00087
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    October 26, 2018
    Report Date
    October 30, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. TO DATE, APOLLO HAS NOT RECEIVED THE DEVICE. 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. POSSIBLE COMPLICATIONS OF THE USE OF THE ORBERA365¿ SYSTEM INCLUDE: INJURY TO THE LINING OF THE DIGESTIVE TRACT AS A RESULT OF DIRECT CONTACT WITH THE BALLOON, GRASPING FORCEPS, OR AS A RESULT OF INCREASED ACID PRODUCTION BY THE STOMACH. THIS COULD LEAD TO ULCER FORMATION WITH PAIN, BLEEDING OR EVEN PERFORATION. SURGERY COULD BE NECESSARY TO CORRECT THIS CONDITION.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA365 INTRAGASTRIC BALLOON HAD A CASE OF GASTRIC PERFORATION. THE BALLOON WAS EXTRACTED, THE PATIENT WAS SENT URGENTLY TO SURGERY TO UNDERGO A SLEEVE GASTRECTOMY. ACCORDING TO THE PHYSICIAN, THE HOLE IN THE STOMACH WAS LARGE AND CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480223 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 AF01763

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention