MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON

Model Number B-50012

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 03/17/2021 a review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "inflation and early removal" as follows: each physician and patient should evaluate the risks associated with endoscopy and intragastric balloons (see complications below) and the possible benefits of a temporary treatment for weight loss prior to use of the orbera365¿ system.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, acute pancreatitis, spontaneous inflation, ulceration, gastric and esophageal perforation, and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications of the use of the orbera365¿ system include: death due to complications related to intestinal obstruction, gastric perforation, is possible.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.

Event Description

Balloon inflated and was removed successfully and a replaced with a new device.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON
• 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 ; CS
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 11529042
• MDR Text Key: 243702639
• Report Number: 3006722112-2021-00019
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/03/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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