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

Model Number B-50000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.The device has not yet been received by apollo.Device labeling addresses the reported event of deflation as follows: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes (greater than 700 cc).Deflated devices should be removed promptly.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: balloon deflation and subsequent replacement.

Event Description

Reported as: a patient with the orbera intragastric balloon had bluish urine.The "balloon ruptured." the device has been removed.

Manufacturer Narrative

Medwatch sent to fda on 08/02/2017.Device evaluation summary: a visual examination was performed on the received balloon noted to be discolored, the shell was dark bluish green in appearance, and the valve was light brown in appearance.White particles were noted on the inner and outer surfaces of the shell.An opening was noted on the radius of the shell of the balloon approximately three inches away from the center patch/valve.As the device was note returned with a fill tube, a sample fill tube was used for further device testing.A valve test was performed, and noted the flow of di water was continuous and unobstructed.An air leak test was performed, and leakage was noted from one tear on the posterior portion of the device shell.The tear was approximately two inches in length.Under microscopic analysis, the apparent origination point of the tear was noted to be striated, and consistent with device removal activities.White particulate matter of an unknown origin was noted to be attached to 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6136162
• MDR Text Key: 61151315
• Report Number: 3006722112-2016-00360
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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: Physician
• Device Expiration Date: 08/21/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2793366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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 Age: 42 YR
• Patient Weight: 79