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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 Insufficient Information (3190)
Patient Problem Sudden Cardiac Death (2510)
Event Date 01/29/2016
Event Type  Death  
Manufacturer Narrative

Medwatch sent to fda on 03/02/2016 further information has been requested of the initial reporter, including patient history and if a copy of the autopsy report or any other lab tests are available. To date, no additional information has been received by apollo 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). 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. Complications of routine endoscopy include: cardiac or respiratory arrest (these are extremely rare and are usually related to severe underlying medical problems).

 
Event Description

A company representative received a notification from a physician reporting: a patient had the orbera intragastric balloon placed, "who progressed well in the first days but died in the 10th day. The patient had a heart attack and the autopsy report was not conclusive. " apollo's approach to compliance is to resolve all doubts in favor of reporting. As the event occurred so closely to the implant date, and the autopsy results are inconclusive, apollo will report this event to the fda. There is no evidence at this time of a device malfunction.

 
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Brand NameORBERA INTRAGASTRIC BALLOON SYSTEM
Type of DeviceINTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC.
1120 s. captial 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
CS
Manufacturer Contact
laura leboeuf
1120 s. capital of texas hwy
bldg 1, ste 300
austin, TX 78746
5122795141
MDR Report Key5474189
MDR Text Key39472874
Report Number3006722112-2016-00034
Device Sequence Number1
Product Code LTI
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberP140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2016
Is This An Adverse Event Report? Yes
Device Operator
Device EXPIRATION Date05/22/2017
Device MODEL NumberN/A
Device Catalogue NumberB-50000
Device LOT Number2744814
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/22/2015
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: 03/02/2016 Patient Sequence Number: 1
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