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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Inflammation (1932); Vomiting (2144)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.A device history record (dhr) review was performed and found the subject product met all specifications and requirements in effect at the time of manufacture.Device labeling addresses the reported event 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.

Event Description

Reported as: a patient with the orbera intragastric balloon had "persistent vomiting and large mass in abdomen, presented to emergency department." physician noted, "despite [patient's] obesity there was a large swelling in [the] upper abdomen which alerted clinically this was not right.A ct scan was performed which noted "over inflation (with air/fluid level) and pancreatitis." the device was removed.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 20/sep/2018.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.White and blue particles were noted on the inner and outer surface of the balloon shell.A valve test was performed and no blockage was observed.An air leak test was performed and leakage was observed on the anterior portion of the shell and eight openings on the radius of the shell.Under microscopic analysis, the openings are all observed to have surgical damage, consistent with device removal activities.Black particles were noted on the inner surface of the valve channel.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin TX 78746
• MDR Report Key: 7031391
• MDR Text Key: 92846329
• Report Number: 3006722112-2017-00404
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/30/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF00832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUSCOPAN; ONDANSETRON; SYMBICORT; TURBOHALER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 100