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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Vomiting (2144); Abdominal Distention (2601)

Event Date 03/05/2018

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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such.Complications: 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.

Event Description

Reported as: a patient with the orbera intragastric balloon had "felt sick with vomiting, abdominal distension and motion sickness.Eda performed which confirmed hiperinflated balloon." the device was removed.

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 01-may-2018.Device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the balloon shell to be discolored, as it was dark blue in appearance.Dark blue, black and white particles were noted on the outer surface of the shell.A sample fill tube was used for device testing.A valve test was performed, and when di water was injected into the valve, the flow of fluid was continuous and unobstructed.An air leak test was performed, and leakage was noted from one opening on the anterior portion of the shell, approximately 1.2 inches away from the center patch.Under microscopic analysis, the edges of the opening were noted to have striated edges, consistent with surgical damage and device removal activities.Degradation was observed on the shell and center patch.Brown particulate matter was noted to cover approximately 10% of the outer surface of the shell; yellow particulate matter was noted to cover approximately 30% of the outer surface of the center patch.Yellow and brown particles were observed on the inner surface of the valve channel.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin TX 78746
• MDR Report Key: 7422041
• MDR Text Key: 105397035
• Report Number: 3006722112-2018-00106
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/27/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2914458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 60