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

Catalog Number B-50000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Dehydration (1807); Inflammation (1932); Blood Loss (2597); Constipation (3274)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The shell was noted to be discolored, and was brown in appearance.Brown particles were noted on the inner surface and valve of the device.A valve test and fill tube test were performed, and no blockage or resistance to flow was noted.An air leak test was performed, and the device was noted to be leaking.A microscopic analysis was performed, and noted striated openings, consistent with surgical removal of the device.The events reported are surgical/physiological complications and analysis of the device generally does not assist apollo in determining a probable cause for these events.Device labeling addresses the possible outcomes of irritation/inflammation (gastritis) and bleeding 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.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: 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.Injury to the digestive tract during placement of the balloon in an improper location such as in the esophagus or duodenum.This could cause bleeding or even perforation, which could require a surgical correction for control.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.

Event Description

Reported as: a patient with the orbera intragastric balloon had "major gastric bleeding, probable gastritis from the balloon.Patient was not on a ppi pre-op, the initial endoscopy showed minor antral gastritis, biopsies were completed, histology was normal - no significant gastritis.The patient was not sick or vomiting post procedure.An additional scope post op was completed in which on examination, there was no mallory-weiss lower oesphageal tear, no discrete ulcer.The whole stomach after they bled, had a fine erythematous gastritis with reddish patches.The patient was compliant in taking her post op medication - pantoprazole the evening of the procedure.".

Manufacturer Narrative

Supplement #1 medwatch sent to the fda on 06/13/2016.Device labeling as follows: the (b)(6) study: safety events were as expected for the orbera¿ group, with the majority of the orbera¿ group reporting gastrointestinal adverse events during the first two weeks after placement.The most common device-related adverse events were nausea and vomiting (74.2%), abdominal pain (54.8%), gastroesophageal reflux (38.7%), lethargy (32.3%), and dehydration (25.8%).These events typically resolved within two weeks.(b)(6) study: the event of constipation was reported in the (b)(6) clinical study and was experienced by 20% of the participates.

Event Description

Reported as: a patient with the orbera intragastric balloon system was reported to have come in for routine follow up and fainted.Physician originally thought it was from dehydration."when asked about her bowels, she said initial constipation then more normal but she didn't mention she'd had black tarry stools (ie melaena)." the following day the patient came in for another routine visit and fainted again.An ambulance was called and she was taken to the hospital."they did hb showing 52.Transfused 5 units up to 97.".

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5654820
• MDR Text Key: 45193062
• Report Number: 3006722112-2016-00122
• 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,Followup
• Report Date: 04/14/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 10/24/2016
• Device Catalogue Number: B-50000
• Device Lot Number: 2665812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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: 50 YR
• Patient Weight: 89