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

Model Number B-50000

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Dyspnea (1816); Nausea (1970); Pain (1994)

Event Date 07/01/2016

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 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.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.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 reported back pain, breathless, nausea and abdominal pain.X-ray confirmed device was hyperinsufflated." device removed and replaced.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 02/15/2017.Additional information: device available for evaluation?, device evaluated by mfr?, evaluation codes, additional mfr narrative.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.A visual examination was performed on the device, and noted blue and black discoloration on the balloon shell.White, red and brown particles were observed on the outer surface of the shell.White fibers were observed on the outer surface of the shell.Brown particles were observed in the valve.A valve test was performed and flow was continuous and unobstructed.An air leak test was performed and leakage was observed.Under microscopic analysis, one striated opening was observed on the shell, consistent with device removal.The device shell was observed to be degraded.

Manufacturer Narrative

Device evaluation summary: additional testing was performed on the device.Leaking was noted from the valve.Foreign matter was noted in the valve chamber.  the balloon and valve surface were covered in biofilm.  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 0.11 psi.  the inside to outside pressure was noted to be 0.15 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: 5943164
• MDR Text Key: 54447945
• Report Number: 3006722112-2016-00287
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2017
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: 2741840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided; 03/01/2017
• Supplement Dates FDA Received: 02/15/2017; 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2015
• 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: 43 YR
• Patient Weight: 98