MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Pressure Problem (3012)

Patient Problem Neuralgia (4413)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on (b)(6) 2023.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 events of neurological disorder and early removal.Warnings each patient must be monitored closely during the entire term of treatment in order to detect the development of possible adverse events.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, igb inflation after placement (i.E.Spontaneous hyperinflation), ulceration, gastric and esophageal perforation, and other adverse events 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 12 months of placement.Hyperinflation of the igb often warrants its early removal to prevent serious complications such as gastric outlet obstruction and contact ulceration.Because hyperinflation increases the internal pressure of the igb (due to accumulated gas) and may increase the fragility of the igb wall, there is an increased risk of rupture followed by the sudden forceful release of gas and fluid contents when it is punctured or endoscopically manipulated.Therefore, it is suggested that the patient's airway is protected with endotracheal intubation prior to endoscopic removal in order to prevent pulmonary aspiration of the balloon contents.Additionally, in situations in which controlled balloon aspiration is done, it is recommended that mid-stream fluid aspirated from the balloon is sent for bacterial and fungal cultures.Patients with an igb that present with severe abdominal pain that have a negative endoscopy and x-ray may additionally require a ct scan to definitively rule out a perforation.Possible adverse events possible adverse events associated with the use of the igb include: 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.Injury to the digestive tract during placement of the igb in an improper location such as in the esophagus or duodenum.This could cause bleeding and perforation, which could require a surgical or endoscopic correction for control.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach, delayed gastric emptying and/or the igb blocking the outlet of the stomach.It is even theoretically possible that the igb could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Injury to the lining of the digestive tract as a result of direct contact with the endoscope, the igb, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

Event Description

After 16 moths of having the balloon removed the patient report that while the balloon was implanted that she was having blackout due to the balloon was pushing against her vagal nerve.The patient was experiancing dehydrated and when the patient was hydrated she did not experiance any other blackout.The patient has other medical conditions that the doctor stated without letting us know thise conditions.The patient was in the hospital for two weeks with the balloon still implanted without any blackouts.Balloon was removed successfully.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 10/apr/2023.Additional information: the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been 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.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.

• Brand Name: ORBERA365¿ 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 ; 5122795114
• MDR Report Key: 16283419
• MDR Text Key: 308940152
• Report Number: 3006722112-2023-00005
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• 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): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female