MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Model Number RSM 101

Device Problem Deflation Problem (1149)

Patient Problem Pain (1994)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Reshape¿ integrated dual balloon system instructions for use (ifu) addresses the known and anticipated potential events of "pain", "deflation" and "early removal" as follows: warnings: intestinal obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.Patients experiencing any symptoms of an intestinal obstruction (e.G., acute onset of abdominal pain, nausea or vomiting) should be counseled to seek immediate care.Patients may not observe or report the presence of blue-green urine following a balloon deflation.Patients should be counseled to seek immediate care if any symptoms of an intestinal obstruction such as acute abdominal pain, nausea or vomiting develop.The maximum placement period for the reshape dual balloon is 6 months.The risk of intragastric balloon deflation and intestinal obstruction (and therefore possible complications related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months.The reshape¿ valve sealant is necessary to seal the device valves and prevent balloon leakage.Failure to use the specified amount of valve sealant will result in balloon leakage and deflation, and increase the risk of intestinal obstruction (and therefore possible complications related to intestinal obstruction) 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 signs and symptoms of balloon 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 signs and symptoms.Subjects who are found at retrieval endoscopy to have a gastric ulcer should be placed on 6 - 8 weeks of therapeutic proton pump inhibitor (ppi) medication and followed closely.After completing 6 - 8 weeks of ppi treatment, subjects experiencing potential ulcer symptoms or signs such as abdominal pain or discomfort, dyspepsia, anemia or dark stools should be considered for endoscopic examination to assess ulcer resolution.Potential risks associated with an endoscopic procedure and sedation include adverse reaction to sedation (headache, muscle pain, nausea), anaphylaxis, cardiac arrest, death, hypoxia, myocardial infarction, perforation, infection, pneumonia, and respiratory distress.Potential risks associated with the reshape dual balloon include ulceration, perforation, significant gastric bleeding, need for blood transfusions, emergency endoscopic therapeutic intervention, abdominal pain, abdominal spasms, nausea, vomiting, bloating, belching, heartburn, dysphagia, dehydration, and sore throat.These complications may be severe enough to require early removal of the reshape dual balloon.A fully inflated, partially filled or a leaking distal balloon could lodge in the gastric outlet causing a pyloric obstruction which can produce a mechanical impediment to gastric emptying and lead to gastric outlet obstruction, requiring endoscopic balloon drainage and removal.Although the reshape dual balloon design provides an anti-migration feature, there is the potential risk of device migration and intestinal obstruction.The risk of intestinal obstruction is increased if the device is not removed after 6 months.If intestinal migration occurs, the device may pass through the intestine and be passed with stool.However, surgical or endoscopic removal may be required.Death due to intestinal obstruction is possible and has been reported with other intragastric balloons.Additional risks associated with the reshape dual balloon include adverse events related to weight loss and balloon deflation with subsequent early removal.A potential outcome of use of the reshape dual balloon is insufficient or no weight loss.

Event Description

Received from reshape on 12nov2019.They had received it via medwatch mw5090562.From medwatch: reshape duo balloons for weight loss, the balloons burst inside my stomach.The blue dye that was inserted did not show signs of color in my urine.Had terrible stomach pains for months and was told it was normal and i experienced bad odor in urine and a very dark yellow color.This balloon sat in my stomach for 6 months and i notice a problem around 3 months where my appetite increased back and i reported this to the clinic and was told to eat more protein first.I paid $7500 and didn't get any results and not even a replacement.I was told by the dr that reshape duo the company was discontinuing this balloon, and he only had a few left because it was going off market.Went on (b)(6) 2019 to get balloons removed and they informed me that the balloons had burst open and photos was taken and it was reported in my medical records.Fda safety report id# (b)(4).

Manufacturer Narrative

Supplement #1 - medwatch submitted to the fda on 01/jul/2020.

• Brand Name: RESHAPE INTEGRATED DUAL BALLOON SYSTEM
• Type of Device: INTEGRATED DUAL BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9447407
• MDR Text Key: 183977065
• Report Number: 3006722112-2019-00194
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: B001RSM1011
• UDI-Public: B001RSM1011
• Combination Product (y/n): N
• PMA/PMN Number: P140012
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: RSM 101
• Device Catalogue Number: RSM 101
• Device Lot Number: 180723-003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention