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

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Perforation (2001)

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 16/jun/2023.A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pregnancy related complications" are as follows: warnings · each patient must be monitored closely during the entire term of treatment in order to detect the development of possible adverse events.Each patient should be instructed regarding symptoms of deflation (i.E.Collapse), gastrointestinal obstruction, ulceration, gastric and esophageal perforation, acute pancreatitis, igb inflation after placement (i.E.Spontaneous hyperinflation) and other adverse events which might occur and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.· patients must be advised that the igb is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of igb placement increase the risk of igb deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when igbs are filled to a larger volume than indicated (greater than 700cc).· pregnancy or breast-feeding contraindicates use of this device.Should pregnancy be confirmed at any time during the course of treatment, the device should be removed as soon as it is safely possible.Additional information: the device has not been returned for analysis, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.

Event Description

Patient reported that she was not receiving the care she expected from her doctor.She also reported after the implatation of the balloon she became pregnant.The patient report having a miscarriage in (b)(6) of 2022.She continued with the balloon program and then in (b)(6) of 2022 she had the first balloon removed dues to having gastric output obstruction and sepsis.During the balloon removal she had a second balloon placed on the same day.A second report was filed under (b)(4) and was filed with the fda under mdr # 3006722112-2023-00131.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 17142541
• MDR Text Key: 317994083
• Report Number: 3006722112-2023-00128
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• 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 Sex: Female