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

Model Number B-4800

Device Problems Inflation Problem (1310); Air/Gas in Device (4062)

Patient Problems Diarrhea (1811); Nausea (1970); Vomiting (2144); Abdominal Distention (2601)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

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 event of "inflation, vomiting, nausea; obstruction; ulcer and early removal" as follows: each physician and patient should evaluate the risks associated with endoscopy and intragastric balloons (see complications below) and the possible benefits of a temporary treatment for weight loss prior to use of the orbera¿ system.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.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, acute pancreatitis, spontaneous inflation, ulceration, gastric and esophageal perforation, 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 orbera¿ system include: death due to complications related to intestinal obstruction, gastric perforation, is possible.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.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.

Event Description

Patient presented with vomiting, nausea, obstruction, ulcer and inflation of the balloon.The device was removed for patients safety.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON,,
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX
• MDR Report Key: 11678723
• MDR Text Key: 247996405
• Report Number: 3006722112-2021-00021
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: (01)10811955020619
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2021
• 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 Outcome(s): Required Intervention
• Patient Weight: 79