BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA365 INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 8691583 · Received June 12, 2019

    Report

    Report Number
    3006722112-2019-00086
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    October 18, 2018
    Report Date
    October 28, 2018
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    PMA / PMN Number
    P140008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    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 WAS NOT ABLE TO INDICATE THE DEVICE SERIAL AND LOT NUMBER. APOLLO ENDOSURGERY HAS REQUESTED FURTHER INFORMATION ON THE REPORTED EVENT OF PULMONARY EMBOLISM. TO DATE, APOLLO HAS NOT RECEIVED THE REQUESTED INFORMATION. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. AS APOLLO CONCLUDES THAT THE ROOT CAUSE FOR THIS INCIDENT IS UNKNOWN, WITH LIMITED INFORMATION PROVIDED FROM THE REPORTER, WE CANNOT ASCERTAIN AN APPROPRIATE RISK PROBABILITY. IN REVIEWING THE RISK DOCUMENTATION, "PULMONARY EMBOLISM" IS CURRENTLY CAPTURED IN THE APPLICATION FAILURE MODES AND EFFECTS ANALYSIS (AFMEA) RELATED TO PLACEMENT OF THE BALLOON WITH A CONTRAINDICATION ("ANY OTHER MEDICAL CONDITION THAT WOULD NOT PERMIT ELECTIVE ENDOSCOPY SUCH AS POOR GENERAL HEALTH OR HISTORY AND/OR SYMPTOMS OF SEVERE RENAL, HEPATIC, CARDIAC AND/OR PULMONARY DISEASE"). AS THERE IS NO DEFINITIVE INFORMATION IN THE COMPLAINT RELATED TO THE CAUSE OF THE PULMONARY EMBOLISM REPORTED, THE RISK DOCUMENTATION DOES NOT NEED TO BE UPDATED AT THIS TIME. 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, 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.

    Description of Event or Problem · 1

    REPORTED AS: A PATIENT WITH THE ORBERA365 INTRAGASTRIC BALLOON HAD DEVELOPED A PULMONARY EMBOLISM. IT IS UNKNOWN IF THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485898 ORBERA365 INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON LTI APOLLO ENDOSURGERY, INC. B-50012 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention