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

Model Number B-50000

Device Problems Improper Flow or Infusion (2954); Material Integrity Problem (2978)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda on 08/16/2016.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the events as follows: 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: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Indications for use: physicians have reported the concurrent use of medications which reduce acid formation or reduce acidity.Silicone elastomer is degraded by acid.Moderating the ph in the stomach should prolong the integrity of the orbera system.

Event Description

Reported as: a patient with the orbera intragastric balloon was experiencing nausea and vomiting frequently."clinic advised that the patient has been in constant contact and following treatment and patient underwent scan that showed an enlarged orbera and presented for an early extraction.Upon visualization during endoscopy the orbera did not appear to be enlarged but it was noticed that there was a substance covering a large proportion of the orbera.The orbera was punctured and the fluid was aspirated, it was noticed during the aspiration that the orbera was deflating differently than expected becoming shorter and thicker in diameter rather than thinner and longer.After the fluid was removed the orbera was grasped and extraction commenced, at the area of the epiglottis, approximately 10cm distal of the mouth, the graspers tore material and became dislodged, from this point, each time the grasper was engaged, the orbera would tear and the grasper would dislodge, repeatedly.Upon inspection of the orbera fragments it was noticed that the material was very friable.It was decided to not push the orbera back into the stomach blindly and with the use of laryngoscope and blade and long atraumatic forceps the anesthetist was able to grasp the orbera however as with the endoscopic graspers the orbera material continued to tear, after some morcellation a good purchase was made on the orbera and it was extracted.Patient was kept in hospital overnight for observation.".

• 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: 5879799
• MDR Text Key: 52286453
• Report Number: 3006722112-2016-00243
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2744847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 56