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

Model Number B-50000

Device Problems Use of Device Problem (1670); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Device labeling addresses the reported event as follows: 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.A minimum fill volume of 400 ml is required for the balloon to deploy completely from the placement assembly.After filling the balloon, remove the fill kit from the fill tube.Connect a syringe directly to the fill tube luer-lock and produce a gentle suction on the placement catheter by withdrawing the plunger of the syringe.You will not withdraw fluid as the valve will seal with the vacuum created.

Event Description

Reported as: physician reported implanting a patient with the orbera intragastric balloon and noted "during implantation after injecting 360 ml of solution, the balloon disconnected." the physician chose to allow the balloon remain placed in the stomach.The device was implanted for little more than a month.At the time, patient then had an endoscopy and the physician noted "withered balloon.Fear of migrating and obstructing.Besides the insufficient weight, the balloon came with defect." the device was removed and replaced.

Manufacturer Narrative

Device evaluation summary: a visual examination was performed on the received balloon.The device was noted to be discolored, and the shell and center patch were blue in appearance.White particles were noted on the outer surface of the shell.An opening was noted on the posterior portion of the shell, approximately three inches from the center patch.The opening was circled in blue ink.As the device was not received with the fill tube, a sample fill tube was used for device testing.A valve test was performed, and the flow of di water was continuous and unobstructed.An air leak test was performed, and the balloon was leaking from three separate openings on the shell.Two openings on the anterior portion of the balloon were located approximately 1.5 inches from the center patch.Under microscopic analysis, the openings in the shell were noted to be sharp and striated, and consistent with damage from a removal tool.The third opening, which was circled in blue ink, was located on the posterior portion of the balloon, opposite the center patch and valve.The opening in the shell was noted to be striated, consistent with damage from a removal tool.Brown particulate matter was observed inside the valve channel.

• 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: 6555428
• MDR Text Key: 74773967
• Report Number: 3006722112-2017-00167
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

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: 05/10/2018
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2908358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• 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: 23 YR
• Patient Weight: 81