MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA¿ INTRAGASTRIC BALLOON SYSTEM

Model Number B-4800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Vomiting (2144); Constipation (3274)

Event Type  malfunction  

Event Description

Patient went to er with the following symptoms: pain, nausea, vomiting, intolerance and constipation.With an endoscopicwhere a needle was used to deflate the balloon and the balloon was removed successfully.

Manufacturer Narrative

Initial medwatch submitted to the fda on 23/jan/2023.A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "deflation, vomiting and early removal "as follows: "the physiological response of the patient to the presence of the orbera¿ 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 orbera¿ system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically as this is indicative of an igb deflation.A patient who's deflated (i.E.Collapsed) igb has moved into the intestines must be monitored closely for an appropriate period of time (at least 2 weeks) to confirm its uneventful passage through the intestine.Abdominal or back pain, either steady or cyclic.Deflation and subsequent replacement." deflated device should be removed promptly.Possible adverse events: intestinal obstruction by the igb.An insufficiently filled igb or a leaking igb that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel or adhesion formation, which may occur after previous surgery on the bowel, the igb may not pass and could cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Insufficient or no weight loss.Igb deflation (i.E.Collapse) and subsequent replacement.Additional information: the device has not been returned for analysis and attempts to gather more information from the reporter is not visible as this is a literature review, and the author does not have the information for the device.The investigator determined a device history record (dhr) review is not possible.Device evaluation summary: the devicei s not returning ,was discarded.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 16225994
• MDR Text Key: 308786662
• Report Number: 3006722112-2023-00012
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female