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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 B-50000
Device Problem Insufficient Information
Event Date 09/10/2017
Event Type  Death  
Manufacturer Narrative

Medwatch sent to the fda on (b)(6) 2017. Apollo received notice that the device would not be returned. Device labeling addresses the reported event as follows: warnings and precautions: 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: - death due to complications related to intestinal obstruction is possible. -gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon. -a feeling of heaviness in the abdomen. -abdominal or back pain, either steady or cyclic. -injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach. This could lead to ulcer formation with pain, bleeding or even perforation. Surgery could be necessary to correct this condition. Complications of routine endoscopy include: -digestive tract injury or perforation.

 
Event Description

Reported as: a patient with the orbera intragastric balloon had contacted their physician one week post placement noting discomfort with upper abdominal pain and a feeling of fullness. The physician advised the patient to come in for an evaluation and the vital signs and o2 saturation was normal. The physician noted there was some epigastric tenderness, otherwise the patient had a soft abdomen and general impression was this was typical symptomology seen during the first week of treatment. The patient spoke to the physician later that evening noting they were still in pain and the physician requested the patient to be seen the following morning. The patient passed away the following morning. It was reported that the patient had a gastric perforation with intra-abdominal hemorrhage and blood in the airways. A necropsy was performed.

 
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Brand NameORBERA INTRAGASTRIC BALLOON SYSTEM
Type of DeviceINTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC
1120 s. capital 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
Manufacturer Contact
laura lebouef
1120 s. capital of texas hwy
bldg. 1, ste. 300
austin , TX 78746
5122795141
MDR Report Key7067558
Report Number3006722112-2017-00395
Device Sequence Number1
Product CodeLTI
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation Physician
Type of Report Initial
Report Date 11/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device EXPIRATION Date05/10/2018
Device MODEL NumberB-50000
Device Catalogue NumberB-50000
Device LOT Number2908361
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/29/2017 Patient Sequence Number: 1
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