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

Model Number B-4800

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

Patient Problems Inflammation (1932); Vomiting (2144); Ulcer (2274); Blood Loss (2597)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported event 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.To prevent ulcers, it is recommended that the patient start a program of oral proton pump inhibitors (ppis) for approximately 3-5 days prior to orbera® placement so a maximal gastric acid suppression effect will be present on the day of placement.It is recommended that the ppi dose be given sublingually after orbera® placement if nausea and/or vomiting are present.A regimen of 40mg per day of an oral ppi should be continued as long as the orbera® is in place.Other medications that are started prophylactically should be continued after orbera® placement until they are no longer needed.Furthermore, subjects will be directed to avoid medications known to cause or exacerbate gastroduodenal mucosal damage.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.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.Injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding and perforation, which could require a surgical correction for control.Injury to the lining of the digestive tract as a result of direct contact with the balloon, 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.Possible complications of routine endoscopy & sedation: potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed.

Event Description

Reported as: a patient had the orbera intragastric balloon was on a ppi and was doing very well with the balloon at 3 weeks.During the third week patient had two bleeding episodes.The first episode was short lived melena and dark stool.Patient went to hospital, endoscopy showed coffee grounds emesis.Received 3 units of blood that stabilized patient and was discharged.Forty eight hours later recurrent melena which persisted.Admitted again before able to complete outpatient gastrointestinal (gi) testing to determine the site of bleed.Unclear the etiology of bleed.During second hospitalization patient received another 3 units of blood and was transported to local hospital for intragastric balloon removal.Device was removed.Operative report noted no obvious blood present but coffee ground material suspicious for possible old blood.Some fairly mild gastritis and superficial small ulcer was noted at the gastric antrum above the pylorus which was non-bleeding.Some fairly mild esophagitis in area was also noted but no obvious active site of bleeding.Patient was stabilized and discharged with instruction to undergo outpatient lower gi testing.Patient is interested in another balloon in if there is nothing serious.Physician will wait and assess the patient before placing second balloon.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 06/26/2018.Device summary evaluation: a visual examination was performed on the returned balloon.The shell was noted to be discolored, as it was green in appearance.Black particulate matter was noted in the valve channel.Black particles were noted on the outer surface of the balloon shell.Two openings were noted on the balloon shell: one on the anterior portion of the shell and one on the radius of the shell.A valve test was performed, and the flow of di water was continuous and unobstructed.An air leak test was performed, and the balloon was noted to be leaking from seven separate openings on the anterior portion of the shell.Under microscopic analysis, all openings on the anterior portion of the balloon shell were noted to have striated edges, consistent with damage from a surgical tool.Yellow, black, and gray particulate matter was 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: 7327432
• MDR Text Key: 102017157
• Report Number: 3006722112-2018-00074
• 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: 06/20/2018

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: Physician
• Device Expiration Date: 08/25/2019
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF01203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATRION; EMEND; OMEPRAZOLE; PHENERGAN; SCOPOLAMINE PATCH; ATRION; EMEND; OMEPRAZOLE; PHENERGAN; SCOPOLAMINE PATCH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 76