MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

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

Patient Problems Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Hernia (2240)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Further information has been requested of the initial reporter regarding: implant date, explant date, patient information, and patient current condition.To date, no additional information has been received by apollo.A review of the device labeling notes the following: warnings and precautions: 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.Complications: possible complications of the use of the orbera365¿ system include: 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.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.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.

Event Description

Reported as: a patient with the orbera365 intragastric balloon system, "three days following insertion, the patient presented with severe abdominal pain and had a bmi of 60.Upon endoscopic view of the stomach it was seen that there was gastric necrosis hence a laparoscopic gastrectomy was performed.[physician] oversewed the perforation of the stomach wall.The patient also required an omentum hernia repair.The patient was admitted to itu post operatively.The patient remained unwell and upon examination free air and fluid was found to be present.The caecum was intact and a right hemi-colectomy was performed.Following the laparotomy the wound was left "open" used abthera therapy (negative pressure therapy).When the abdomen was closed it took four hours.Post operatively abdominal binders were used one above and below the stoma.From the use of binders the patient unfortunately resulted with pressure necrosis on [their] back.[physician] feels that the patient has significant underlying pathology as any relative "minor" intervention causes a significant increase in abdominal pressure, this no doubt is related to [their] underlying bmi > 60 but could also be linked to [patient] collagen.Whilst the balloon did not fail, as was initially reported with it "exploding", the balloon was intact and had neither spontaneously inflated or deflated, it is felt that the root cause of this patient's ongoing issues are all related post operatively to the balloon insertion.The patient has had one laparotomy and 8/9 laparoscopies since admission and has been in itu for the past "3 or 4 weeks".The patient has a tracheostomy but is spontaneously breathing.

Event Description

Additional information noted via product field note: hernia.She had a prolonged admission (3 months) requiring multiple laparotomies and bowel resection for perforation of the colon, colostomy formation and repair of abdominal wall hernia.She was discharged home on (b)(6) 2019.This was a life threatening complication of the intragastric balloon causing perforation.

Manufacturer Narrative

• Brand Name: ORBERA365 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: 9014081
• MDR Text Key: 159518777
• Report Number: 3006722112-2019-00161
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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: 10/18/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF02213
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention