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); Pain (1994); Swelling (2091); Vomiting (2144); Cramp(s) (2193); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling notes the following: the current orbera365® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "obstruction", "pain", "dehydration", "bloating", "bowel complications", "cramping", "vomiting", "late removal" as follows: 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.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.Possible complications of the use of orbera365¿ include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel, as may occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.The risk of obstructions may be higher in patients who have diabetes, a dysmotility disorder, or who have had prior abdominal or gynecological surgery, so this should be considered in assessing the risk of the procedure.Bowel obstruction can result in death.Bacterial growth in the fluid which fills the balloon.Rapid release of this fluid into the intestine could cause infection, fever, cramps and diarrhea.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.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.Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms.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.

Event Description

Medical information review of medical journal article: laparoscopic management of a migrated intragastric balloon causing mechanical small bowel obstruction: a case report and review of the literature.Authors: hay, d et al.A (b)(6)-year-old woman had an intragastric balloon placed endoscopically for weight control 13 months previously (orbera¿ intragastric balloon system).She presented to the emergency department with a four-day history of intermittent abdominal cramps and vomiting.Contrast enhanced computed tomography confirmed the presence of the intragastric balloon within the small bowel.At laparoscopic retrieval, the deflated intragastric balloon was found impacted in the terminal ileum approximately 15 cm from the ileocaecal valve.The balloon was retrieved by enterotomy and primary closure of the ileum without event.Additional adverse events noted pain, mild dehydration, and a distended abdomen.The patient made an uneventful recovery and was discharged on the second postoperative day.The patient was well, with no complications following her emergency surgery at follow up three months after discharge.

Manufacturer Narrative

Supplement #1-medwatch sent to the fda on 05/mar/2020.Correction: d4 - the model number and catalog number of the device are unknown.Additional information: the device was not returned to the apollo device analysis laboratory.Analysis of the device was not possible.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476688
• MDR Text Key: 178631620
• Report Number: 3006722112-2019-00204
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: Health Professional
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 113