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

Model Number B-50000

Device Problem Connection Problem (2900)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: a visual examination was performed on the received undeployed balloon.The balloon was noted to be discolored, green and blue in appearance.Trace amounts of fluid was noted in the inner surface of the device shell.White particles were noted on the inner and outer surfaces of the shell, and black particles were noted on the inner surface of the shell.As the device was not received with the fill tube, a sample fill tube was used for device testing.A fill tube test was performed, and o blockage was noted.A valve test was performed and the flow of di water was continuous and unobstructed.An air leak test was performed, and noted the balloon was leaking from an opening on the radius of the shell.Under microscopic analysis, no particles or foreign material was noted in the valve channel/hole.The opening was noted to be striated, and consistent with damage from a device removal tool.Device labeling addresses the reported event as follows: warnings and precautions: 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.Proper positioning of the placement catheter assembly and the orbera® system balloon within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.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.The orbera® system balloon is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.Complications: possible complications of the use of the orbera® system include: intestinal obstruction by the balloon.An insufficiently inflated balloon or a leaking balloon that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way through into the colon and be passed with stool.However, if there should be a narrow area in the bowel, as might occur after prior surgery on the bowel or adhesion formation, the balloon may not pass and then may cause a bowel obstruction.If this occurs, percutaneous drainage, surgery or endoscopic removal could be required.Balloon placement and inflation: note: during the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: rapid fill rates will generate high pressure which can damage the orbera® system valve or cause premature detachment.

Event Description

Reported as: the patient had the orbera intragastric balloon for 4 days.The physician reported, "orogastric insertion of the intragastric balloon without difficulty until 40 cm of the upper dental arch.Positioned endoscope in retrovision with visualization of the balloon valve just below the lower esophageal sphincter.Then, initiated the insuflation under direct vision with 60 ml syringe.No difficulty of insuflation until around 450 ml.Suddenly the device had resistance to inflation and then the connection of the catheter with the balloon was ruptured." the balloon remained implanted in the patient for 4 days and was explanted due to "balloon migrated to the den (pyloric antrum) and physician chose to remove the balloon to resolve the patient's symptoms and replace it with a new balloon.".

• 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
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6792680
• MDR Text Key: 82689249
• Report Number: 3006722112-2017-00300
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/05/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2904025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 86