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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Vomiting (2144)

Event Date 11/19/2016

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to fda on 12/28/2016.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 reported events 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.Complications: 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.

Event Description

Reported as: a patient with the orbera intragastric balloon was experiencing "excessive vomiting and abdominal volume." physician confirmed "hyperinsuflation" and device was removed.

Manufacturer Narrative

Supplement #1: additional information.

Manufacturer Narrative

Device evaluation summary: the device was returned to the apollo device analysis laboratory.A visual examination was performed on the device, and noted blue discoloration on the shell.Yellow particles were observed on the outer surface of the shell, patch and valve.A valve test was performed and the flow of di water was continuous and unobstructed.An air leak test was performed and leakage was observed.Under microscopic analysis, thirteen small striated openings and one large striated opening, 5 mm in length were observed, all consistent with device removal activities.Yellow and brown particles were observed in the valve channel.

• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6209067
• MDR Text Key: 63420620
• Report Number: 3006722112-2016-00390
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/25/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2744821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2015
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 60