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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Internal Organ Perforation (1987); Vomiting (2144)

Event Date 02/02/2016

Event Type  Death  

Manufacturer Narrative

Medwatch sent to fda on 10/23/2018.The reporter of the event was asked to return the product for analysis, and to provide device and patient information.To date, neither the device nor any further information has been received by apollo.Review of the device 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, 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.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.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.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.Complications of routine endoscopy include: digestive tract injury or perforation.

Event Description

Literature review performed: "intra-gastric balloon outcomes in super-obesity - a 16-year city centre hospital series" hutan ashrafian et al.Journal of surgery for obesity and related diseases 2018, summary of events; the mortality rate in the cohort of patient was 1.4%, with a total of 3 deaths over 16 years.Two out of three deaths occurred within 10 days due to acute gastric perforation secondary to excess vomiting and one patient suffered cardiac arrest at 4 weeks post-operatively.One report of death within 10 days due to acute gastric perforation secondary to excess vomiting and the other report of a patient's death due to cardiac arrest at 4 weeks post-operatively were both captured in the allergan safety database.This is for the second report of death occurring within 10 days due to acute gastric perforation secondary to excess vomiting.

Manufacturer Narrative

Supplement #2: medwatch sent to fda on 07-mar-2019.Apollo endosurgery received an email request from the fda dated march 4, 2019 for supplemental information to be submitted on mdr report number 3006722112-2018-00267.Attn: (b)(6).Response to fda request: contained herein is the apollo response to the further questions based on our response to the letter received from the agency regarding report number 3006722112-2018-00267.Please specify for each of the two death, the cause of death, the death occurrence date and associated information.If you have additional information regarding the 3rd death, please state in the same way so we know which information is for which death.Answer: below is additional information from allergan regarding the two deaths (prids 88583 and 543221): allergan prid 88583 received on 13/jul/2001: "rupture of fundus of the stomach thought to be due to vomiting after excessive fluid intake following bib insertion.Patient developed peritonitis and expired on 9-jul-01." from their investigation, allergan concluded this event was not device related.The reporter in this case was chelsea and westminster hospital in the united kingdom, and the placing physician was dr.Jeremy thompson.Additional information received from the reporter to allergan states: "excerpts from the surgeon's letter reporting the event: 'the patient experienced persistent nausea and vomiting following insertion and was treated by hospitalization, intravenous fluids and anti-emetic medication.The patient developed acute abdominal pain on the 19th june (approximately 40 hours following balloon insertion) and was subsequently found to have ruptured the fundus of his stomach with spillage of gastric contents into the peritoneal cavity.There was a linear tear in the anterior fundus measuring approximately 3 cm.The balloon was removed through a separate gastrotomy and the perforation and gastrotomy were closed.I believe he spontaneously ruptured his stomach whilst vomiting following balloon insertion possibly associated with excessive oral fluid intake, although he had been appropriately counseled by our specialist dietitian about fluid intake and diet following balloon insertion.'" allergan prid 543221 received on 12/nov/2009: "patient died a few days after bib insertion.Follow-up findings revealed that the physician stated that the patient had cardiac problems and event was not product related." from their investigation, allergan concluded this event was not device related.The reporter in this case was chelsea hospital in the united kingdom, and the placing physician was dr.Evangelos efthimious.Additional information received from the reporter to allergan states: "my verbal communication was that the sudden death was related to cardiac causes and not to a complication from the balloon.E.Efthimiou" additional information received by apollo regarding the second gastric perforation death in the article: apollo ccn0004141, mdr #3006722112-2018-00267: apollo was able to obtain additional information from an author of the article, related to patient information such as: initial weight and bmi, relevant tests, patient history, and co-morbidities.This information was submitted via a supplemental medwatch to the fda on 31/dec/2018.A copy of the post-mortem report has not been provided, and the device will not be returned to apollo for analysis.

• 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
• MDR Report Key: 7996709
• MDR Text Key: 124788468
• Report Number: 3006722112-2018-00267
• 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,Followup
• Report Date: 03/04/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 03/04/2019
• Supplement Dates FDA Received: 12/31/2018; 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR