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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Pain (1994)

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda on 11/16/2016.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: precautions: 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.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: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Abdominal or back pain, either steady or cyclic.

Event Description

Reported as: a patient with the orbera intragastric balloon had "complaint about severe abdominal pain.The balloon was hyper-inflated".Device was removed and replaced.

Manufacturer Narrative

Supplement #1.Additional information: device available for evaluation?, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The received device was noted to be discolored and the shell was dark blue in color.Yellow particles were noted on the outer surface of the shell and valve patch.The valve was discolored, and was blue in color.An opening was noted on the radium of the shell.A valve test was performed and observed the flow of di water was continuous and unobstructed.An air leak test was performed and a leakage was noted from an opening on the device shell.Under microscopic analysis, the opening was noted to be striated which is consistent with damage from a surgical tool.Also noted under microscopic analysis, white particles on the patch of the device.

• 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 capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6107544
• MDR Text Key: 60093017
• Report Number: 3006722112-2016-00311
• 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,Followup
• Report Date: 10/21/2016

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: 05/28/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2747821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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: 38 YR
• Patient Weight: 100