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 10/19/2016

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 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 evelopment 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.Patients reporting loss of satiety, increased hunger and/or weight gain should be examined endoscopically, as this is indicative of a balloon deflation.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 reported "couldn't feel the balloon any longer and wasn't losing weight." it was noted the "device was almost fully deflated." device was removed.

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 02/10/2017.Additional information: report date, device available for evaluation?, date received by mfr , type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The device was noted to be discolored, green in appearance.Two openings were observed on the shell of the device.White particles were noted on the outer surface of the shell.Black particles were observed on the inner surface of the device shell.A valve test was performed and observed the flow of di water to be continuous and unobstructed.An air leak test was performed and the device was leaking from two separate openings on the shell, each approximately 10-15 mm in length.Under microscopic analysis, the openings were noted to be striated which is consistent with damage from a removal tool.Also under microscopic analysis, black and brown particles were noted in the valve channel/hole.

• 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 capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6118392
• MDR Text Key: 60628545
• Report Number: 3006722112-2016-00344
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/25/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2793388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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: 59 YR
• Patient Weight: 82