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

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: warning 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.Complications possible complications of the use of the orbera® system include: 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.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.

Event Description

Reported as: a patient with the orbera intragastric balloon had reported "the balloon was full of air." the patient had the device removed and replaced.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 23/jul/2019.Additional information h3, h6, h10 device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the device was received deployed.The balloon was noted to be discolored, as the shell and center patch were dark brown and dark green in appearance.A valve test was performed and the flow of fluid was continuous and unobstructed.An air leak test was performed and leakage was observed from three openings on the radius portion of the shell.A fill tube test was performed and no blockage was observed.Under microscopic analysis, all three openings noted on the radius of the shell was observed to have striated edges, consistent with damage from a surgical tool.No particles were noted 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: 8651070
• MDR Text Key: 147611176
• Report Number: 3006722112-2019-00122
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF00817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR