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

Model Number B-4800

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Cramp(s) (2193); Patient Problem/Medical Problem (2688)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to fda on 12/27/2018.The reporter of the event was asked to indicate product serial number.To date, apollo has not received the device information.Device labeling addresses the reported event as follows: precautions: placement of the balloon within the stomach produces a delay in gastric emptying and this can create a variety of expected and predictable reactions including 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 throughout the entire placement duration.Most patients acclimate to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced after placement, physicians should prescribe proton pump inhibitors (ppis) and antiemetics prophylactically and consider prescribing antispasmodics or anticholinergic medications for cramping due to accommodation of the balloon, and/or prokinetic medications for symptoms due to the delay in gastric emptying).Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent 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.In preparation for removal, some patients may have retained contents in the stomach.Some patients may have a clinically significant delay in gastric emptying and refractory intolerance to the balloon, necessitating early removal, and possibly leading to other adverse events.These patients may be at higher risk of aspiration upon removal and/or upon administration of anesthetic.The anesthesia team should be alerted to the risk for aspiration in these patients.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, delayed gastric emptying and/or 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 hyperinflation due to gas production within the balloon.Warnings: spontaneous hyperinflation 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.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, 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.Patients need to be evaluated and the device removed at or within 6 months of placement.

Event Description

Reported as: a patient with the orbera intragastric balloon experienced delayed gastric emptying and vomiting.Patient also reported having stomach pain, cramping for several hours after eating and voluntarily vomits to get rid of that feeling.The patient has not responded to medications and still continued to have nausea and vomiting.An x-ray image confirmed hyperinflation.The device was removed.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 01/28/2019.Additional information: corrected data: device evaluation summary: a visual examination was performed on the returned balloon.The balloon shell was noted to be discolored, as it was orange in appearance.One opening was noted on the anterior portion of the balloon shell.Orange particulate matter was noted on approximately 90% of the outer surface of the balloon shell.As the device was not received with the fill tube, a sample fill tube was used for device testing.A valve test was performed, and the flow of di water was continuous and unobstructed.An air leak test was performed, and leakage was noted from several openings on the balloon shell.Under microscopic analysis, eight openings were noted on the balloon shell: one on the anterior portion, and seven on the radius.All openings were noted to have striated edges, consistent with damage from a surgical tool.Material degradation was noted to be covering approximately 90% of the outer surface of the balloon shell.Orange and red particles were noted on the inner surface of the valve channel.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 8200827
• MDR Text Key: 131786694
• Report Number: 3006722112-2018-00332
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERYTHROMYCIN; PROKINETICS; PROTON PUMP INHIBITORS (PPI); REGLAN
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 69