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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Weight Changes (2607)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.The reporter indicated it would not be returned.The product associated with this report was noted to have been in place for 8 months.Device labeling addresses reported events as follows: indications for use: the maximum placement period for the orbera system is 6 months, and it must be removed at that time or earlier.Caution: 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.This has already been experienced.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.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: insufficient or no weight loss.Balloon deflation and subsequent replacement.

Event Description

Reported as: during the removal procedure for an orbera intragastric balloon, the physician noted that the orbera "was already fully deflated in situ, sitting high in the fundus." additionally, the patient had reported experiencing a lack of satiety and weight loss.The device was removed and replaced.

• 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5331345
• MDR Text Key: 34524182
• Report Number: 3006722112-2015-00596
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 12/04/2015

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: 09/22/2016
• Device Model Number: N/A
• Device Catalogue Number: B-50000
• Device Lot Number: 2655513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• 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: 35 YR
• Patient Weight: 141