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

Model Number B-50000

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

Patient Problems Death (1802); Ischemia (1942); Necrosis (1971); Internal Organ Perforation (1987); Obstruction/Occlusion (2422)

Event Date 06/21/2018

Event Type  Death  

Manufacturer Narrative

The reporter confirmed the explanted device was discarded and will not be return to apollo for analysis.Apollo endosurgery has requested the physician to provide the autopsy report once completed.Review of the device labeling notes the following: warnings and precautions: 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.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, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.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.Blockage of food entering into the stomach.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: patient presented to the hospital not feeling well, a computed tomography (ct) scan was performed and showed free gas and a chronic dilated stomach.Patient was then taken to the operating theatre and a necrotic perforated stomach with free floating food observed.A gastrectomy was performed; 48 hours later the patient had deceased.Prior to hospitalization, it was noted the patient was seen approximately 10 days earlier by the placement physician for a routine follow-up appointment.The patient was noted to be well, and had lost 23 kg since placement.Additional information received from the patient's orbera placement physician: the patient developed intolerance symptoms at 3 months; was sent for an abdominal x-ray which was interpreted as normal.The physician did not view the x-ray, just the report.When the patient was seen by the physician, lab work was obtained; lipase was minimally elevated, and all other labs were normal.The patient's subsequent presentation to the emergency room (er) was unknown to the physician.The patient presented with an acute abdomen from a gastric perforation.The stomach was massively dilated with copious retained food and fluid and there was a perforation with extensive intra-abdominal soiling of food.Unstable post-op course with eventual death.Additional information received from the patient's treating physician: patient presented to the hospital accident and emergency department (a&e) very unwell and had reported to the hospital feeling unwell for a few days.Patient taken to theatre, where the balloon was noted to be sitting in the antrum.Approximately 14 liters of food in stomach; "perforated / ischemic dead stomach" noted and the balloon was removed.A total gastrectomy was performed and the patient was transferred to intensive care unit (icu).Day 2 post-op patient passed away.The coroner was informed, and it was reported an autopsy will be performed.

• 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): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7714774
• MDR Text Key: 114860332
• Report Number: 3006722112-2018-00178
• 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
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF01171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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
• Treatment: ASPIRIN; PLAVIX
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 111