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

Model Number B-50012

Device Problem Leak/Splash (1354)

Patient Problems Discharge (2225); Patient Problem/Medical Problem (2688)

Event Date 11/24/2019

Event Type  malfunction  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.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 events of "bowel complications", "deflation", "early removal" as follows: precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain.Patients will need to immediately contact their physician for any severe or unusual symptoms.Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed during this adjustment period.These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications.Typically the stomach acclimates to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera¿ placement).Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms.The physiological response of the patient to the presence of orbera365¿ 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.Patients need to be evaluated and the device removed at or within 12 months of placement.Clinical data does not exist to support use of an individual orbera365¿ beyond 12 months.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.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.Deflated devices should be removed promptly.Complications: possible complications of the use of the orbera365 system include: balloon deflation and subsequent removal.

Event Description

Reported complaint: "the patient defecated a deflated intragastric balloon.Upon further inspection, a silicone layer rupture about 2-3cm long was discovered.The event took place at the patients home, no medical staff was present.The patient has sent photos of the ruptured device via email and the device itself via post service.The patient refuses a reimplantation.This is the 8th orbera balloon migration event in our clinical experience - further information may be acquired from (b)(6).".

Manufacturer Narrative

Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2019.A balloon was returned discolored with a large hole present.There were no other components returned with the device.Due to the large hole present in the shell, functional evaluation could not be conducted.Observation of the hole shows smooth edges with the edges rolling inward with significant discoloration present on the balloon shell.

Manufacturer Narrative

Supplement #1: the device was returned to the apollo device analysis laboratory on 13/dec/2019.Analysis of the device is ongoing.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476694
• MDR Text Key: 183682880
• Report Number: 3006722112-2019-00203
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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 Expiration Date: 10/17/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF02209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/04/2019; 12/04/2019
• Supplement Dates FDA Received: 12/20/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 86