MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON; INTRAGASTRIC BALLOON,

Model Number B-50012

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

Patient Problems Eructate (1839); Pyrosis/Heartburn (1883); Nausea (1970); Vertigo (2134); Vomiting (2144); Abdominal Distention (2601)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "vomiting, nausea, reflux, bloating, pain, and multiple symptoms" as follows: the physiological response of the patient to the presence of the orbera365¿ 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.Complications: possible complications of the use of the orbera365¿ system include: insufficient or no weight loss.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.Gastroesophageal reflux.

Event Description

Patient presented with vomiting, acid reflux, nausea, vertigo, swelling and flatulence, foul-smelling belching, hard and enlarged stomach area, heart burn and back pain.A scan was done and demonstrated that the balloon was correctly in place.The patient did not lose weight and had their balloon removed.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON
• 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 78746
• MDR Report Key: 11677964
• MDR Text Key: 245766844
• Report Number: 3006722112-2021-00024
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)2020-02-22(10)AF03544
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03544
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention