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

Model Number B-50000

Device Problem Insufficient Information (3190)

Patient Problems Cyanosis (1798); Death (1802); Internal Organ Perforation (1987); Pain (1994); Sepsis (2067)

Event Date 05/10/2016

Event Type  Death  

Manufacturer Narrative

Further information has been requested of the initial reporter, including a copy of the autopsy report or if any other lab tests are available.To date, no additional information has been received by apollo.Device labeling addresses the possible outcomes of pain, stomach perforation and death as follows: 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).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.-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.-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

A company representative received a notification from a physician reporting: a patient had the orbera intragastric balloon placed, and three days later called their doctor to say they were leaving for emergency [in the morning].They reported they were feeling much pain.[the patient] was medicated, exams were performed, and said they were feeling better.Doctor asked patient to call if they would feel pain again.At night, the patient's spouse called the doctor to say they were worried because their spouse was still feeling pain.Doctor asked if patient had vomited and if the pain has increased.Spouse said no.Doctor asked patient's spouse to take the patient to the clinic first thing the following morning.The next morning the patient arrives to the clinic in shock and cyanosis.Oxygen saturation 78%, blood pressure "100 x 60", cardiac frequency 156.Oxygen therapy was performed, "puncture two accesses to hydrate, administered efedrina (1,5 ampoule), buscopan t, 1500 ml of saline solution and 500 ml of sg." patient was sent to a hospital to perform diagnostic testing."patient was stabilized and it was performed complementary exams that identified gastric perforation.In the same day was performed surgery that identified not damaged balloon, with intragastric wall perforation and ischemic adjacent mucosa.Patient did not resist to the septic shock and died the next morning.".

• 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 ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5706677
• MDR Text Key: 46816741
• Report Number: 3006722112-2016-00150
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/26/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2708401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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: 43 YR