BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 15539224 · Received October 4, 2022

    Report

    Report Number
    3006722112-2022-00098
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    June 9, 2022
    Report Date
    September 6, 2022
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    LTI
    UDI-DI
    10811955020725
    PMA / PMN Number
    P140008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM DIRECTIONS FOR USE (DFU) ADDRESSES THE KNOWN AND ANTICIPATED POTENTIAL EVENTS OF EARLY REMOVAL; AND PAIN AS FOLLOWS: THE IGB IS COMPOSED OF A SOFT SILICONE ELASTOMER AND IS EASILY DAMAGED BY INSTRUMENTS OR SHARP OBJECTS. THE IGB MUST BE HANDLED ONLY WITH GLOVED HANDS AND WITH THE INSTRUMENTS RECOMMENDED IN THIS DOCUMENT. THE PHYSIOLOGICAL RESPONSE OF THE PATIENT TO THE PRESENCE OF ORBERA 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. PATIENTS WITH AN IGB THAT PRESENT WITH SEVERE ABDOMINAL PAIN THAT HAVE A NEGATIVE ENDOSCOPY AND X-RAY MAY ADDITIONALLY REQUIRE A CT SCAN TO DEFINITIVELY RULE OUT A PERFORATION. PATIENTS MUST BE ADVISED THAT THE IGB IS INTENDED TO BE PLACED FOR 6 MONTHS MAXIMALLY, AT WHICH POINT REMOVAL IS REQUIRED. LONGER PERIODS OF IGB PLACEMENT INCREASE THE RISK OF IGB DEFLATION (A REDUCTION IN SIZE OF THE DEVICE DUE TO LOSS OF SALINE) WHICH CAN LEAD TO INTESTINAL OBSTRUCTION AND RISK FOR DEATH. THE RISK OF THESE EVENTS IS ALSO SIGNIFICANTLY HIGHER WHEN IGBS ARE FILLED TO A LARGER VOLUME THAN INDICATED (GREATER THAN 700CC). IT IS IMPORTANT TO DISCUSS ALL POSSIBLE COMPLICATIONS AND ADVERSE EVENTS WITH YOUR PATIENT. COMPLICATIONS THAT MAY RESULT FROM THE USE OF THIS PRODUCT INCLUDE THE RISKS ASSOCIATED WITH THE MEDICATIONS AND METHODS UTILIZED IN THE ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH ANY ENDOSCOPIC PROCEDURE, THE RISKS ASSOCIATED WITH THE ORBERA365 INTRAGASTRIC BALLOON SPECIFICALLY, AND THE RISKS ASSOCIATED WITH THE PATIENT'S DEGREE OF INTOLERANCE TO A FOREIGN OBJECT PLACED IN THE STOMACH. POSSIBLE COMPLICATIONS: 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. ABDOMINAL OR BACK PAIN, EITHER STEADY OR CYCLIC GASTROESOPHAGEAL REFLUX. INSUFFICIENT OR NO WEIGHT LOSS. ADDITIONAL INFORMATION: THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE INVESTIGATOR DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT, AS THERE ARE NO OTHER COMPLAINTS AGAINST THIS LOT NUMBER, AF04727.

    Description of Event or Problem · 0

    ABDOMINAL PAIN IN THE EPIGASTRIUM. BALLOON WAS REMOVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539996 ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM INTRAGASTRIC BALLOON SYSTEM LTI APOLLO ENDOSURGERY, INC. B-50012 AF04727 10811955020725

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male