MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365 INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information regarding this late medwatch report: during a february 2019 internal review of post-market surveillance data for all apollo products, apollo executive management was made aware that complaints associated with the ce marked orbera365 (12-month intragastric balloon) were not being assessed for reportability consistent with the requirements of 21 cfr 803.Consideration for reportability in the us was incorrectly established based on the difference in the indications for use (i.E.12-month placement vs 6-month placement) vs considerations for 'similar devices' marketed by apollo.The orbera365 12-month intragastric balloon is a 'similar device' as compared to the orbera 6-month balloon approved via pma p140008, and as such, complaints will be assessed for mdr reportability going forward.Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The balloon shell was noted to be discolored, as it was dark green in appearance.Brown particles were noted on the center patch.A valve test was performed, and when di water was injected into the valve, the flow of fluid was continuous and unobstructed.An air leak test was not feasible, as the tear covered approximately 40% of the balloon shell.Under microscopic analysis, the apparent origination point of the tear was noted to have striated edges, consistent with surgical damage.Material degradation was noted to be covering approximately 20% of the outer surface of the shell.Red, white and yellow particulate matter was noted in the valve channel.A review of device lableing notes the following: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).The physiological response of the patient to the presence of the orbera365¿ 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, acute pancreatitis, spontaneous inflation, 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 orbera365¿ system include: balloon deflation and subsequent replacement.

Event Description

Reported as: a patient with the orbera intragastric balloon had a "leak." patient experienced blue in urine.The device was removed.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: tracy whisman ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 9106262
• MDR Text Key: 159686499
• Report Number: 3006722112-2019-00097
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF01965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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