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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Ulcer (2274)

Event Type  malfunction  

Event Description

Complaint from a literature review- patient had the following symptoms - nausea, vomiting, fever, dehydration, pain when urination, and ucler.The balloon was removed successfully.

Manufacturer Narrative

A review of the device labeling notes the following: the device will not be returned for analysis, and since it is not possible to gather more information from the reporter, no additional information will be received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.Additional information: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "intolerance, vomiting, reflux 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.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 14516573
• MDR Text Key: 294771872
• Report Number: 3006722112-2022-00044
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/26/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female