BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBERA INTRAGASTRIC BALLOON SYSTEM

    MDR report key: 24879503 · Received April 14, 2026

    Report

    Report Number
    3005099803-2026-01363
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    February 18, 2025
    Report Date
    May 15, 2026
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    LTI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G2: LITERATURE CASE REPORT: INTRAGASTRIC BALLOON PLACEMENT FOR WEIGHT LOSS IN LVAD PATIENTS: A BRIDGE TO HEART TRANSPLANTATION. BLOCK D4, H4 DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THROUGH THE ARTICLE " CASE REPORT: INTRAGASTRIC BALLOON PLACEMENT FOR WEIGHT LOSS IN LVAD PATIENTS: A BRIDGE TO HEART TRANSPLANTATION". IGB PLACEMENT WAS PERFORMED UNDER GENERAL ENDOTRACHEAL ANESTHESIA (GETA) USING A STANDARD ADULT GASTROSCOPE AND FOLLOWING STANDARD PROTOCOL FOR PLACEMENT OF THE DEVICE. HEPARIN (12 U/KG/HR) INFUSION WAS STOPPED 5 HOURS PRIOR TO THE PROCEDURE AND RESUMED THE FOLLOWING DAY POST IGB PLACEMENT. THE IGB WAS INSTILLED WITH 550 ML OF A SOLUTION OF SALINE AND METHYLENE BLUE AND WAS DEPLOYED IN THE STOMACH. THE PATIENT PRESENTED SEVERE NAUSEA AND VOMITING RESULTING FROM A PSEUDO-OBSTRUCTION CAUSED BY MOVEMENT OF THE BALLOON IN THE STOMACH LEADING TO MALPOSITIONING WITHIN THE ANTRUM. IT REQUIRED ENDOSCOPIC REPOSITIONING OF THE BALLOON WHICH WAS UNEVENTFUL. THE PATIENT TOLERATED IGB THERAPY WITHOUT COMPLICATIONS AND THE BALLOON WAS SUBSEQUENTLY REMOVED AT THE 6-MONTH PERIOD. IT WAS REPORTED METHYLENE BLUE WAS MIXED IN THE SALINE INJECTED INTO THE IGB. HOWEVER, THE INSTRUCTIONS FOR USE (IFU) INDICATES THAT THE IGB IS PLACED IN THE STOMACH AND FILLED WITH STERILE SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80609 ORBERA INTRAGASTRIC BALLOON SYSTEM IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY UNK-P-ORBERA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention