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 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda on 12/07/2016.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 events as follows: warnings and precautions: the physiological response of the patient to the presence of the orbera system balloon 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.Complications - possible complications of the use of the orbera system 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 had the orbera intragastric balloon placed, and after a period, patient complained about "discomfort and abdominal pain.Doctor requested x-ray exam that confirmed air inside the balloon." the device was removed and replaced.

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 01/25/2017.The device was returned to apollo.A visual examination was performed, and noted the returned device to be discolored, and the shell was blue in appearance.White particles were also noted on the outer surface of the shell, valve patch and valve channel.An opening/hole was noted on the radius of the device.A valve test was performed and the flow of di water was continues and unobstructed.An air leak test was performed and leakage was noted from a single opening on the radius of the shell.The openings were noted to be striated, consistent with damage from a surgical tool.Under microscopic analysis, black particles were observed in the valve channel/hole.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 26-jul-2017.Device evaluation summary: additional testing was performed on the device.The valve was noted to be leaking.The slit valve was removed from the device using a razor blade for testing.Pressure testing of the slit valve was performed, the outside to inside pressure was noted to be 0.19 psi.The inside to outside pressure was noted to be 0.29 psi.The valve was cross-sectioned along the sealing mechanism, and examined microscopically with a magnification between 20x-60x.The surface of sealing mechanism showed typical axial lines parallel to the valve access due to the blade cutting direction during valve manufacturing.The inner edge of the cut appeared to be more defined than the opposite edge, likely a consequence of the valve slitting process.

• 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6151104
• MDR Text Key: 61665014
• Report Number: 3006722112-2016-00379
• 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,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/26/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2744842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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
• Treatment: PANTOPRAZOL
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 78