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); Nausea (1970); Vomiting (2144); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The consumer reported that the device will not be returned.Therefore no analysis or testing will be done.A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "vomiting", "dehydration" and "reflux" 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.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.Clinical data does not exist to support use of an individual orbera¿ beyond 6 months.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 - 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.Gastroesophageal reflux.

Event Description

The patient reported on 07/oct/19 and stated that they, "[had] been dealing with severe acid reflux, vomiting, and dehydration." apollo's diet coach reported, "the physician placed the patients balloon on (b)(6) 2019, the patients starting weight [was] (b)(6) lbs and currently the patient is (b)(6) lbs.The weekend after the balloon was placed the patient was admitted to the hospital for hydration and observation then discharged home.The patient said they [were] still vomiting and can see food they ate the day before even though the patient is taking zofran.We talked about the patients diet progression, positioning and most importantly communication with the patients doctors.The patient said they were going to be talking with their physician and gave permission for apollo for any further follow up.Patient date of birth (b)(6).On 07/oct/2019 i called and spoke with the physician to discuss this patient's adverse symptoms.The physician said they would follow up with the patient." additional information: on 16/oct/2019 medical information reached out to the physician to request further information after leaving voice mail messages.The physician let me know they had requested the nurse call me with additional information.On 17/oct/2019 the nurse called to provide me with an update for patient ey.The patient had elected to have their balloon removed after experiencing multiple bouts of nausea and vomiting with little to no relief from zofran and reglan prescriptions.The nurse noted the patient had presented to the ed on the (b)(6) 2019 with abdominal pain, nausea, vomiting and was found to be hypokalemic.Patient was admitted to the hospital and given iv hydration.After discharge from the hospital the patient was tolerating a pureed diet with no nausea or vomiting but was experiencing gerd.On (b)(6), the patient reported nausea and vomiting the doctor prescribed reglan.On the (b)(6), one of the doctors felt the patient may be dealing with delayed gastric emptying.Patient continued to experience n/v presented to the ed for iv hydration on (b)(6).On (b)(6) the patient had the balloon removed.Removal was uneventful.The nurse was unable to locate a serial number for the balloon in the patient chart.

Manufacturer Narrative

Supplement # 1-medwatch submitted to the fda on 24/mar/2020.Additional information: d4.

• Brand Name: ORBERA® INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476706
• MDR Text Key: 176848206
• Report Number: 3006722112-2019-00178
• Device Sequence Number: 1
• Product Code: LTI
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR