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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 08/11/2017

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 symptoms.If it is necessary to replace a balloon which has spontaneously deflated, the recommended initial fill volume of the replacement balloon is the same as for the first balloon or the most recent volume of the removed balloon.A greater initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.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.Abdominal or back pain, either steady or cyclic.

Event Description

Reported as: the patient's orbera intragastric balloon was removed due to "patient complaining of pain and vomiting for ten days.Physician performed tomography and confirmed balloon with 1600 ml volume (air and water) in the gastric body.".

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The balloon shell was noted to be discolored, as it was blue in appearance.White particulate matter was noted in the valve hole.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 radius of the shell.Under microscopic analysis, both openings were noted to have striated-edges, consistent with surgical damage and device removal activities.Also under microscopic analysis, white 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
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6990950
• MDR Text Key: 91202089
• Report Number: 3006722112-2017-00356
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/06/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2908357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• 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: 56 YR
• Patient Weight: 79