MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-4800

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 11/jan/2021.After multiple attempts to gather more information from the reporter, no additional information has been received.A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as.02% -.49% of complaints over units sold.A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote".Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "nausea", "vomiting", "pain" and "inflation" as follows: "precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain.Patients will need to immediately contact their physician for any severe or unusual symptoms.Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed during this adjustment period.These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications.Typically the stomach acclimates to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera® placement).Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms." "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 need to be evaluated and the device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual orbera® beyond 6 months." "adverse events: 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 orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach." "possible complications of the use of orbera® include: 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." "spontaneous over inflation." "warnings: spontaneous over inflation of an indwelling balloon has been reported in patients with orbera®.Symptoms of balloon over-inflation include 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.".

Event Description

Mw5097989 reported: spontaneous over inflation or orbera intragastric balloon resulting in abdominal pain, nausea/ vomiting.

Manufacturer Narrative

Supplement #1 submitted to the fda on 27/jul/2021.The balloon was to be removed in (b)(6) 2020 but she did not follow up because of concerns about getting severe acute respiratory syndrome coronavirus disease 2019 (sars covid-19) during her scheduled medical visit.The balloon was removed without complications.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 11148774
• MDR Text Key: 226332888
• Report Number: 3006722112-2021-00001
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR