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

Model Number B-50012

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

Patient Problem Vomiting (2144)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted to the fda.Apollo has not received the product at this time.Therefore no analysis or testing has been done.A review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "deflation" as follows: 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

Apollo sales representative reported on behalf of health professional via product field notes (pfn), "patient called physician, that they just [had] vomited the balloon out of [their] body.".

Manufacturer Narrative

Supplement #1 submitted on 27/jan/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 29/oct/2020.Ccn0005294 deflated balloon with a significant amount of blue/green discoloration and fungus on the shell returned.Under microscopic analysis, the large hole on the shell has rounded edges and rolls inward.Due to the large hole, functional evaluation of the device could not be conducted.The complaint has been verified as it is uncertain how the large hole was created as the shell rolls inward which is not consistent with a puncture from a surgical instrument.

• 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
• MDR Report Key: 9447391
• MDR Text Key: 183977669
• Report Number: 3006722112-2019-00187
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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 Model Number: B-50012
• Device Catalogue Number: B-50012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention