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

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

Patient Problems Dehydration (1807); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Cramps (2543)

Event Type  Injury  

Manufacturer Narrative

Initial medwatch sent to the fda.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 "pain ", "vomiting", "dehydration", "cramping" and "nausea" as follows: the physiological response of the patient to the presence of the orbera system balloon 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.Placement of the balloon within the stomach produces a delay in gastric emptying.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 due to the delay in gastric emptying.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 temporarily 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.Complications: possible complications of the use of the orbera system 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.

Event Description

Reported as: patient presented bad cramping and pain along with nausea and vomiting.Patient had to go get iv fluids because patient was dehydrated.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 24/mar/2020.

• 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
• MDR Report Key: 9808731
• MDR Text Key: 183975439
• Report Number: 3006722112-2020-00038
• 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: 02/14/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR