MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365® INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Vomiting (2144)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda.The reporter stated that the device will not be returned for analysis.A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as.02% -.49% of complaints over units sold.A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote".Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides.The current orbera365® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain ", "vomiting", "bloating" and "early removal" as follows: "the physiological response of the patient to the presence of the orbera365 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 orbera365 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: "on (b)(6) 2019 - continual vomiting.On (b)(6) 2019 - goes to the emergency department and abdominal cat scan.Balloon overly distended with hydroair level of 950 cc.Vomits persist.".

• Brand Name: ORBERA365® 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 9617305
• MDR Text Key: 183979407
• Report Number: 3006722112-2020-00010
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/16/2020

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: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF02711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2019
• 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: 45 YR