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

Model Number B-4800

Device Problem Fluid/Blood Leak (1250)

Patient Problem Laceration(s) (1946)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Device labeling addresses the reported event as follows: possible complications of routine endoscopy & sedation: potential risks associated with upper endoscopic procedures include, but are not limited to: abdominal cramping and discomfort from the air used to distend the stomach, sore or irritated throat, bleeding, infection, tearing of the esophagus or stomach that could lead to perforation, and aspiration pneumonia.The risk increases if additional procedures are performed.Precautions: placement of the balloon within the stomach produces a delay in gastric emptying and this can create a variety of expected and predictable reactions including a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed throughout the entire placement duration.Most patients acclimate to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced after placement, physicians should prescribe proton pump inhibitors (ppis) and antiemetics prophylactically and consider prescribing antispasmodics or anticholinergic medications for cramping due to accommodation of the balloon, and/or prokinetic medications for symptoms due to the delay in gastric emptying).Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms.The physiological response of the patient to the presence of orbera¿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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual orbera¿ beyond 6 months.Deflated devices should be removed promptly.Patients should be advised that balloon deflation may lead to serious adverse events including bowel obstruction and need for emergency surgery.Patients should immediately call their physician to receive instructions on preparing for removal of the balloon adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications - possible complications of the use of orbera¿ include: balloon deflation and subsequent replacement.

Event Description

Reported as: a patient with the orbera intragastric balloon had gone in for removal and it was noted the device was deflated.Upon removing the deflated balloon, the patient had a minor laceration at the ge junction, requiring an endoscopic clip placement to approximate the laceration.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 25/jan/2019.Additional information: device evaluation summary: the device was returned to apollo for analysis, and visual examination was performed on the device which noted the balloon was received with brown discoloration noted on the center patch and shell.White particles were observed on the outer surface of the shell.A valve test was performed and noted the flow of fluid was continuous and unobstructed.An air leak test was performed and leakage was observed.Under microscopic analysis, ten openings were observed on the shell: eight openings were located on the anterior portion of the shell and two openings were noted on the radius.All openings were noted to have striated edges consistent with surgical damage from device removal activities.The inner surface of the slit valve was noted to have brown discoloration.Brown particles were observed in the inner surface of the slit valve.

• Brand Name: ORBERA 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: 8153609
• MDR Text Key: 130498481
• Report Number: 3006722112-2018-00301
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2019
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF00580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 83