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

Model Number B-50000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Pain (1994)

Event Date 09/10/2017

Event Type  Death  

Manufacturer Narrative

Medwatch sent to the fda on (b)(6) 2017.Apollo received notice that the device would not be returned.Device labeling addresses the reported event 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: - death due to complications related to intestinal obstruction is possible.-gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.-a feeling of heaviness in the abdomen.-abdominal or back pain, either steady or cyclic.-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.

Event Description

Reported as: a patient with the orbera intragastric balloon had contacted their physician one week post placement noting discomfort with upper abdominal pain and a feeling of fullness.The physician advised the patient to come in for an evaluation and the vital signs and o2 saturation was normal.The physician noted there was some epigastric tenderness, otherwise the patient had a soft abdomen and general impression was this was typical symptomology seen during the first week of treatment.The patient spoke to the physician later that evening noting they were still in pain and the physician requested the patient to be seen the following morning.The patient passed away the following morning.It was reported that the patient had a gastric perforation with intra-abdominal hemorrhage and blood in the airways.A necropsy was performed.

• Brand Name: ORBERA 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): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7067558
• MDR Text Key: 93224170
• Report Number: 3006722112-2017-00395
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/10/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2908361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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: 51 YR
• Patient Weight: 78