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

Model Number B-50000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Vomiting (2144)

Event Date 09/08/2017

Event Type  Injury  

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 events as follows: 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 symptoms.Deflated devices should be removed promptly.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.-balloon deflation and subsequent removal.

Event Description

Reported as: a patient with the orbera intragastric balloon had started "vomiting with stomach contents with methylene blue." device was removed and replaced.

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo for analysis, and visual examination was performed on the device, and noted the balloon shell to be discolored, as it was light brown in appearance.Trace amounts of clear fluid were observed on the inner surface of the balloon 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 two openings on the shell; one on the radius of the device, and the other on the posterior of the shell, approximately 3.0 inches away from the center patch.Under microscopic analysis, both openings were noted to have striated edges, consistent with surgical damage and device removal activities.

• 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7154863
• MDR Text Key: 96113432
• Report Number: 3006722112-2017-00426
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF00576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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 Age: 24 YR
• Patient Weight: 133