MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Constipation (3274); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 28/jan/2021.All four cases were diagnosed and treated for acute pancreatitis.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain", "nausea", "vomiting" and "pancreatitis" as follows: "precautions: placement of the balloon within the stomach produces a delay in gastric emptying and 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.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 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." "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." "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, 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." "abdominal or back pain, either steady or cyclic." "acute pancreatitis." "warnings: acute pancreatitis has been reported as a result of injury to the pancreas by the balloon.Patients experiencing any symptoms of acute pancreatitis (i.E.Acute abdominal pain, nausea or vomiting) should be counseled to seek immediate care." "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, gastric and esophageal perforation 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.".

Event Description

Literature review reported: 4 orbera patients presented with pancreatitis, epigastric pain, nausea, vomiting, and/or constipation.2 of the 4 orbera patients had their balloon removed.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital 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, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 11247771
• MDR Text Key: 233282495
• Report Number: 3006722112-2021-00007
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 01/28/2021
• 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): Hospitalization; Required Intervention