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

Model Number B-50012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 11/26/2017

Event Type  Injury  

Manufacturer Narrative

Apollo has not received the product at this time.Therefore no analysis or testing has been done.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.A review of the device labeling notes the following: warnings and precautions: 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, 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: 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.

Event Description

Reported as: a patient with the orbera intragastric balloon had the device for three months and feels constipated.Patient reported nausea, "tummy ache", acid reflux, and vomiting.Additional information noted: "after about two weeks i was vomiting on a daily basis." by week five, the patient noted they were "dreadfully sick" and "not digesting anything"."i thought the balloon had blocked my bowel, i was weak my hair was falling out by the handful, the acid was constantly burning my throat, so bad it was painful to talk"."i couldn't breath".Patient stated that at three months the body felt like it was "closing down" and the patient was "frozen to my bones".Patient felt at this point the only option was to get the device removed.The device was removed.Per physician: removed the orbera due to intolerance; nausea and vomiting.

• 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: 9098675
• MDR Text Key: 160756049
• Report Number: 3006722112-2019-00078
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR