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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Nausea (1970); Internal Organ Perforation (1987); Vomiting (2144)

Event Date 11/07/2016

Event Type  Death  

Manufacturer Narrative

It is unknown if the device will be returned to apollo for analysis.Device labeling addresses the reported event as follows: indications for use: caution: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months.This has already been experienced.Warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes (greater than 700 cc).Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Some obstructions have reportedly been associated with patients who have diabetes or who have had prior abdominal surgery, so this should be considered in assessing the risk of the procedure.Bowel obstructions can result in death.Proper positioning of the placement catheter assembly and the orbera® system balloon within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.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.Complications: death due to complications related to intestinal obstruction is possible.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.Complications of routine endoscopy include: digestive tract injury or perforation.Balloon placement and inflation: filling should always be completed under direct visualization (gastroscopy).Integrity of the valve should be confirmed by observing the valve lumen as the balloon fill tube is removed from the valve.A balloon with a leaking valve must be removed immediately.A deflated balloon can result in a bowel obstruction, which can result in death.Bowel obstructions have occurred as a result of unrecognized or untreated balloon deflation.

Event Description

Reported as: healthcare professional reported an orbera intragastric balloon patient's death due to "intestinal perforation following insertion of gastric balloon.Patient had experienced "intolerance" symptoms such as nausea, emesis, abdominal discomfort, inability to tolerate liquid or food in any amounts.Computed tomography (ct) scan demonstrated gastric perforation.".

Event Description

Clarification of information received from the initial reporter of "intestinal perforation" noted the event was diagnosed by ct scan as a gastric perforation only.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7160722
• MDR Text Key: 96315689
• Report Number: 3006722112-2018-00004
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 66 YR