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

Model Number B-4800

Device Problem Obstruction of Flow (2423)

Patient Problem Ischemia (1942)

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

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 "obstruction", "ischemia" , "bowel complications", and "other " 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 of the use of orbera® include: gastric outlet obstruction.A partially-filled balloon (i.E., <400 cc), or a leaking balloon could lead to gastric outlet obstruction, requiring balloon removal.It is also possible for a fully inflated (400-700 cc) balloon to lodge itself in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require surgical removal." "adverse health consequences resulting from weight loss." "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." "blockage of food entering into the stomach." "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." us pivotal study: us pivotal clinical study documents, the event of constipation experienced by 20%, dehydration experienced by 1.3%, gastritis experienced by 1.9% and the event of gastric perforation with sepsis and peritonitis was experienced by 0.6% of 160 participants."contraindications: prior gastrointestinal or bariatric surgery." "a large hiatal hernia or > 5cm hernia or <= 5 cm with associated severe or intractable gastro-esophageal reflux symptoms." "warnings: patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically as this may be indicative of a balloon deflation." "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." additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

Event Description

Reported: patient had a bowel obstruction and as well as atrial fibrillation.Balloon was removed for patient safety.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 03/feb/2022.Additional information:g6, h10.The device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.Device evaluation summary: assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.This type of complaint will continue to be monitored as appropriate.

• 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 13054520
• MDR Text Key: 286888758
• Report Number: 3006722112-2021-00129
• Device Sequence Number: 1
• Product Code: LTI
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female