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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported event as follows: warnings and precautions: 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, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.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.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.

Event Description

Reported as: a patient with the orbera intragastric balloon was experiencing abdominal discomfort, nausea and vomiting for about a month.Physician maintained the symptoms controlled with medication during this period.Patient had lost 20 kg.Later there was significant worsening of the symptoms and an endoscopy confirmed hyperinflation in the balloon.The physician removed and replaced the device.

Manufacturer Narrative

Device summary evaluation: a visual examination was performed on the returned balloon.The balloon shell was noted to be discolored, as it was green in appearance.Three openings were noted on the balloon shell: two on the radius of the shell and one on the posterior portion of the shell.Material appeared to be missing from the openings on the balloon shell.As the device was not received with the fill tube, a sample fill tube was used for device testing.A valve test was performed, and the flow of di water was continuous and unobstructed.An air leak test was performed, and leakage was noted from three separate openings on the balloon shell: two on the radius of the shell and one on the posterior portion of the shell.Under microscopic analysis, both openings on the radius of the shell were noted to have striated edges, consistent with damage from a surgical tool.The opening on the posterior portion of the balloon shell was noted to have striated edges, consistent with damage from a surgical tool.A small portion of the shell was noted to be missing from both openings on the radius of the shell, and the opening on the posterior portion of the shell.Black and yellow particulate matter was noted in the valve channel.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 7634816
• MDR Text Key: 112323687
• Report Number: 3006722112-2018-00157
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/23/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2925441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR