MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA365 INTRAGASTRIC BALLOON SYSTEM; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number B-50012

Device Problems Deflation Problem (1149); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: exact date unknown, event estimated to have occurred in the month of march 2024.Block h6: medical device code a1401 captures the reportable event of balloon deflated.Medical device code a010402 captures the reportable event of balloon migration.

Event Description

It was reported to boston scientific corporation that an orbera intragastric balloon system was implanted into a patient on an unknown date.The balloon was discovered to be missing during the scheduled removal procedure, on an unknown date, indicating the balloon deflated and migrated from the patient.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 imdrf code a1401 captures the reportable event of balloon deflated imdrf device code a010402 captures the reportable event of balloon migration imdrf device code f2202 captures the reportable event of gastroscopy procedure.Investigation summary: the device was not returned for product analysis.Instructions for use (ifu)/label review: a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu contains detailed device information and instructions for the device use.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: balloon deflated and balloon migration.Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a risk review was completed and confirmed that the event of "endoscopic procedure, balloon deflated and balloon migration" were defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: for the as reported balloon deflated and balloon migration these adverse events are known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions), for this reason these events are catalogued as "known inherent risk of device.".

Event Description

It was reported to boston scientific corporation that an orbera365 intragastric balloon system was implanted into a patient on (b)(6) 2023.The balloon was discovered to be missing with a gastroscope during the scheduled removal procedure, on (b)(6) 2024, indicating the balloon deflated and migrated from the patient.There were no patient complications reported as a result of this event.

• Brand Name: ORBERA365 INTRAGASTRIC BALLOON SYSTEM
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19082159
• MDR Text Key: 340682484
• Report Number: 3005099803-2024-01425
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Lot Number: AF05361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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 Age: 51 YR
• Patient Sex: Male