MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON SYSTEM

Model Number B-50000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device labeling notes the following: the risk documentation for this device establishes the occurrence ranking for the reported event "inflation" as "remote", which is defined by apollo as.02% -.49% of complaints over units sold.A review for the intragastric balloon products for the failure mode "inflation" is performed during quarterly complaint analysis meetings (cam) and has demonstrated that global balloon inflation rate remains at "remote".Therefore, apollo determined that the reported event is occurring within the range of the expected frequency and severity for this reported event, as referenced in the cam meeting slides.The current orbera® intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain", "vomiting" as follows: "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." orbera® system placement and inflation (step-by-step) - slowly fill the balloon with sterile saline, 50 cc at a time.Repeat up to 700 cc (14 strokes).Recommended full volume is up to 700 cc.Minimum fill volume is 400 cc.

Event Description

Patient presented with pain and vomiting.The balloon hyperinflated.

Manufacturer Narrative

Supplement #1 submitted to the fda on 03/feb/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 12/jan/2021.A deflated balloon with a significant amount of blue/green discoloration and fungus on the shell was returned.There are several slits on the shell observed with the naked eye.Under microscopic analysis, the openings on the shell were noted to have striated edges, consistent with damage from a surgical tool for removal purposes.Functional evaluation could not be conducted due to the slits on the shell.The complaint could not be verified as it is uncertain how the inflation occurred.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 10969236
• MDR Text Key: 221288491
• Report Number: 3006722112-2020-00121
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020541
• UDI-Public: (01)10811955020541(17)2021-07-02(10)AF03046
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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 Expiration Date: 07/02/2021
• Device Model Number: B-50000
• Device Catalogue Number: B-50000
• Device Lot Number: AF03046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 87