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U.S. Department of Health and Human Services

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

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APOLLO ENDOSURGERY, INC. ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
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.
 
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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 Key5331345
MDR Text Key34524182
Report Number3006722112-2015-00596
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P140008
Number of Events Reported1
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 Date09/22/2016
Device Model NumberN/A
Device Catalogue NumberB-50000
Device Lot Number2655513
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2015
Initial Date FDA Received12/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age35 YR
Patient Weight141
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