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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Discomfort (2330)

Event Date 04/30/2018

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 is addressed 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.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.

Event Description

Reported as: a patient with the orbera intragastric balloon complained of abdominal discomfort.Endoscopy verified that the balloon was filled with air and liquid.Device was removed.

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.A large tear was noted on the posterior portion of the balloon, covering approximately 15% of the balloon shell, and traveling parallel to the radius of the shell.The center patch was noted to be discolored, as it was yellow in appearance.Black particulate matter was noted in the valve channel.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 the large tear on the posterior portion of the balloon shell, covering approximately 15% of the shell.Dark green particulate matter was noted on the inner surface of the valve channel.The slit valve was noted to be discolored, as it was dark green in appearance.Under microscopic analysis, the apparent origination point of the large tear on the posterior portion of the shell, was noted to have striated edges, consistent with damage from a surgical tool.The tear was approximately 3.3 inches in length.

• 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: 7616451
• MDR Text Key: 111912604
• Report Number: 3006722112-2018-00150
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/10/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2920488
• 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: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 80