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 Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Vomiting (2144); Malaise (2359); Sweating (2444)

Event Date 07/15/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch submitted to the fda on 28/aug/2018.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.A review of the labeling notes the following: 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: -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 "entered the emergency of a hospital with part of the stomach necrosed and with rupture in the stomach." patient was hospitalized for nine days.The device was removed.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 05/oct/2018.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The balloon shell was noted to be discolored, as it was green in appearance.Blue particles were noted on the inner and outer surfaced of the balloon shell.Trace amounts of blue fluid were noted on the inner surface of the balloon shell.Black particulate matter was noted in the valve channel.A valve test was performed, and when di water was injected into the balloon valve, the flow of fluid was continuous and unobstructed.An air leak test was performed, and leakage was noted from three separate openings on the balloon shell: one opening was located on the anterior portion of the shell, and two openings were located on the posterior portion of the shell.Under microscopic analysis, all three openings were observed to have striated edges, consistent with damage from a surgical tool and surgical damage from device removal activities.Several non-penetrating nicks/marks were noted on the posterior portion of the balloon shell.Device labeling addresses the reported events as follows: complications: possible complications of the use of the orbera system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.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.Abdominal or back pain, either steady or cyclic.

Event Description

Additional information provided by the physician: difficulties, nausea and vomiting: no symptoms except initial discomfort (2-3 days).Treated with symptomatic medication.24 hours before gastric perforation, the patient began experiencing the major symptoms of discomfort, pain, cold sweating and general malaise.

• 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
• MDR Report Key: 7824877
• MDR Text Key: 118527137
• Report Number: 3006722112-2018-00218
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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: Health Professional
• Device Expiration Date: 06/29/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2927975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR