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 Dehydration (1807); Diarrhea (1811); Pain (1994); Vomiting (2144); Burning Sensation (2146)

Event Date 02/24/2018

Event Type  Injury  

Manufacturer Narrative

The reporter confirmed the explanted device will not be return to apollo for analysis.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 40 mg 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.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.(b)(6) study: the event of dehydration was reported in the (b)(6) clinical study and was experienced by (b)(4) of the participants.

Event Description

Reported as: a patient in the (b)(6) clinical study had difficult time with orbera therapy and had gone to the emergency room (er) because the patient was vomiting up blood.Lab work results showed everything within normal limits so the patient was given iv fluids for dehydration and sent home.The patient was not able to keep fluids down, had diarrhea and was very uncomfortable.Patient reiterated the visit to the er and was unable to take in fluids without vomiting soon after, has a burning sensation/feeling in the stomach."epigastric discomfort" and "gastrointestinal intolerance" were also reported.Patient insisted the balloon be removed.The following day the device was removed.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 03/29/2018.Device labeling is addressed as follows: global product experience and clinical studies: the event of erosion was reported through clinical product surveillance and was experienced by 1% of the participants.

Event Description

Additional information received: at the time of device removal procedure, physician noted "erosive oesophagitis" and "gastric erosion" and indicated these events were not serious adverse events but just an observation during removal.

• 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7381406
• MDR Text Key: 103816953
• Report Number: 3006722112-2018-00089
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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: 09/27/2019
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF01346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/23/2018
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• 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
• Treatment: LISINOPRIL; NORCO; OMEPRAZOLE; XANAX; ZOFRAN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR