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

Model Number B-40800

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

Patient Problems Cardiac Arrest (1762); Death (1802); Internal Organ Perforation (1987); Obstruction/Occlusion (2422)

Event Date 05/25/2018

Event Type  Death  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.The device has not yet been received by apollo.Further information has been requested of the initial reporter regarding: requesting a post mortem report and weight/bmi at time of removal.To date, no additional information has been received by apollo.A review of our manufacturing records show the product met all specifications and requirements in effect at the time of manufacture.Device labeling addresses the reported event as follows: indications for use: caution: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months.This has already been experienced.Warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes (greater than 700cc).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 bib¿ 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.Complications - possible complications of the use of the bib¿ 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.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 bib¿ system intragastric balloon presented to the accident and emergency facility as a high risk patient with advance cardiac disease.The patient had a fast heart rhythm and excessive vagal stimulation.This was confirmed by a ct scan.The patient was transferred to the theatre for device removal.It was observed the patient had a delayed presentation of gastroparesis and a perforation.The perforation was observed after balloon removal and noted due to the expanding pneumoperitoneum.Per the physician, the cause of the perforation was "probable massive gastric over-distention from definite impacted balloon at pylorus.Therefore, spontaneous exacerbated by gas insufflation." the patient died in the itu post device removal from cardiac arrest secondary to the gastric perforation.The physician noted the patient had symptoms approximately one week before presenting for treatment.

• Brand Name: BIB SYSTEM INTRAGASTRIC BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 7934999
• MDR Text Key: 122800700
• Report Number: 3006722112-2018-00144
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2018

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: 07/03/2019
• Device Model Number: B-40800
• Device Catalogue Number: B-40800
• Device Lot Number: AF00968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2017
• 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
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 59 YR