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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
Device Problem Inflation Problem (1310)
Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Perforation of Vessels (2135); Pancreatitis (4481)
Event Type  malfunction  
Manufacturer Narrative
Initial medwatch submitted to the fda on 03/feb/2023.A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of inflation and early removal.The orbera¿ intragastric balloon (igb)system filled to 400cc and 700cc with uninflated system in the foreground."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." "warnings" each patient must be monitored closely during the entire term of treatment in order to detect the development of possible adverse events.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, igb inflation after placement (i.E.Spontaneous hyperinflation), ulceration, gastric and esophageal perforation, and other adverse events which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.Spontaneous hyperinflation of an indwelling igb with gas has been reported in patients with an indwelling igb.Symptoms of significant igb over-inflation include intense abdominal pain, swelling of the upper abdomen (abdominal distension) with or without discomfort, difficulty breathing, gastroesophageal reflux, nausea and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care and should be evaluated for hyperinflation, particularly when persistent abdominal pain, abdominal distension, and food intolerance occur beyond the initial accommodative period of the igb.Plain radiographic films will often demonstrate hyperinflation with a large air-fluid level within the igb and an increase in igb volume compared to the original volume.Hyperinflation of the igb often warrants its early removal to prevent serious complications such as gastric outlet obstruction and contact ulceration.Because hyperinflation increases the internal pressure of the igb (due to accumulated gas) and may increase the fragility of the igb wall, there is an increased risk of rupture followed by the sudden forceful release of gas and fluid contents when it is punctured or endoscopically manipulated.Therefore, it is suggested that the patient's airway is protected with endotracheal intubation prior to endoscopic removal in order to prevent pulmonary aspiration of the balloon contents.Additionally, in situations in which controlled balloon aspiration is done, it is recommended that mid-stream fluid aspirated from the balloon is sent for bacterial and fungal cultures.Patients with an igb that present with severe abdominal pain that have a negative endoscopy and x-ray may additionally require a ct scan to definitively rule out a perforation.The igb is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The igb must be handled only with gloved hands and with the instruments recommended in this document.Gastroesophageal reflux.A feeling of heaviness in the abdomen.Acute pancreatitis.Spontaneous hyperinflation due to gas production within the igb.Abdominal or back pain, either steady or cyclic." caution: fill the igb with sterile saline.An aseptic technique, similar to changing iv fluids (e.G.Use of clean or sterile gloves, sterile syringe, etc.), is recommended.Though the cause of hyperinflation is unknown, it may be caused by fungal or bacterial microbes contaminating the balloon.One recommended mitigation is to avoid contaminating the saline within the balloon with microorganisms that may lead to spontaneous hyperinflation.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.
 
Event Description
Patient had symptoms of abdominal pain, pancreatitis; and vessel damage.Examination showed that the balloon was inflated, tear in the rectus abdomis and the pancreatic duct dilated.The balloon was removed successfully.
 
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Brand Name
ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
Type of Device
INTRAGASTRIC BALLOON SYSTEM
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC
1120 s. captail of texas hwy
bldg 1, ste 300
austin TX 78746
Manufacturer (Section G)
APOLLO ENDOSURGERY COSTA RICA, SRL
coyol free zone
building b 13.3
alajuela, cs CRI
CS   CRI
Manufacturer Contact
adriana russell
1120 s. captail of texas hwy
bldg 1, ste 300
austin, TX 78746
5122795114
MDR Report Key16297154
MDR Text Key308785788
Report Number3006722112-2023-00024
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P14008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/04/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2023
Initial Date FDA Received02/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age53 YR
Patient SexFemale
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