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

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Swelling (2091); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to fda on 08/14/2018.The reporter confirmed the explanted device will not be return to apollo for analysis.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.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.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: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way through into the colon and be passed with stool.However, if there should be a narrow area in the bowel, as might occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, percutaneous drainage, surgery or endoscopic removal could be required.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.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.

Event Description

Reported as: a patient with the orbera intragastric balloon experienced spontaneous over- inflation occurred in the patient's stomach, resulting the need for immediate device removal.After the swallow test, the stomach caused a complete stoppage of the balloon.The device had been the line of the antrum-corpus.The patient also experienced intense abdominal pain, swelling of the abdomen, difficulty breathing, and continuous vomiting which resolved with the balloon removal.

• 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: 7781383
• MDR Text Key: 117301009
• Report Number: 3006722112-2018-00209
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF01640
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 97