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); Increased Sensitivity (2065); Sweating (2444)

Event Date 03/15/2018

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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications: possible complications of the use of the orbera® system include: abdominal or back pain, either steady or cyclic.

Event Description

Reported as: a patient with the orbera intragastric balloon was experiencing abdominal pain, sweating and cold extremities.An x-ray of the abdomen and endoscopy confirmed air inside the balloon.Device was removed and replaced.

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.Green particles were noted on the outer surface of the center patch.Five separate openings were noted on the balloon shell: four on the anterior portion of the shell, and one on the radius of the 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 the balloon was noted to be leaking from five separate openings on the shell: four on the anterior portion of the shell, and one on the radius of the shell.Under microscopic analysis, all the openings on the anterior portion of the balloon shell were noted to have striated edges, consistent with damage from a surgical tool.The opening on the radius of the shell, located approximately 2.1 inches from the center patch, was noted to have striated edges, consistent with damage from a surgical tool.Green particulate matter was noted on the entrance to the valve channel.The slit valve was noted to be discolored, as it was dark blue in appearance.

• 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: 7472521
• MDR Text Key: 106974645
• Report Number: 3006722112-2018-00116
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/12/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2908368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRONCHODILATORS
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 78