MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

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

Patient Problems Abdominal Pain (1685); Perforation (2001); Vomiting (2144); Abdominal Cramps (2543); Hematemesis (4478)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 28/dec/2020.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 events of "vomiting", "pain" and "stomach perforation" 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 orbera365¿ 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 orbera365¿ 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 12 months of placement.Clinical data does not exist to support use of an individual orbera365¿ beyond 12 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 orbera365¿ 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.Possible complications of routine endoscopy & sedation - potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach, and aspiration pneumonia.The risk increases if additional procedures are performed.Warnings: proper positioning of the placement catheter assembly and the orbera balloon within the stomach (using measured distance from the incisors via the insertion tube markings) is necessary to allow for proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.Failure to confirm proper positioning may cause injury to the esophagus, duodenum, or pylorus.

Event Description

Patient presented with hematemesis, pain and perforation.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 24/feb/2021.The reporter noted that the device will not be returned for analysis.Additional information: a2, a3, b5, b7, d6b, h6 and h10.

Event Description

Patient presented with hematemesis, pain, perforation, abdominal cramps, vomiting which resulted in balloon removal.

• Brand Name: ORBERA365 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
• MDR Report Key: 11078694
• MDR Text Key: 223836119
• Report Number: 3006722112-2020-00132
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)2021-12-16(10)AF03423
• 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: 02/24/2021

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 Expiration Date: 12/16/2021
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03423
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR