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

Model Number	B-4800
Medical Device Problem Codes	Deflation Problem (1149); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Weight Changes (2607)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a orbera365 intragastric balloon system was implanted on (b)(6), 2023.It was reported that the patient reported being hungry all the time (loss of satiety, increased hunger) and weight gain.An endoscopic procedure was performed on (b)(6) 2024 as the physician reported symptoms may be indicative of balloon deflation.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 impact code f2202 is being used to capture the reportable event of endoscopic procedure.Impact code f0101 is being used to capture the reportable event of therapeutic response decreased.Device code a1401 is being used to capture the reportable event of deflation problem.
Additional Manufacturer Narrative
Block h6 correction to b5 for additional information, correction to h6 removal of deflation code.Block h6 impact code f2202 is being used to capture the reportable event of endoscopic procedure.Impact code f0101 is being used to capture the reportable event of therapeutic response decreased.
Event or Problem Description
It was reported to boston scientific corporation that a orbera365 intragastric balloon system was implanted on (b)(6) 2023.It was reported that the patient reported being hungry all the time (loss of satiety, increased hunger) and weight gain.Endoscopic procedure was performed on (b)(6) 2024 as physician reported symptoms may be indicative of balloon deflation.There were no patient complications reported as a result of this event.Per additional information received on july 21, 2024, the patient reported increased hunger following 4 months post implantation, and after losing 35 pounds of weight.The balloon was found to be in good condition and in the perfect position at the time of the endoscopic procedure, with no evidence of deflation." additionally, it was reported that the balloon was implanted on (b)(6) 2023 and the removal procedure was in (b)(6) 2024.The orbera intragastric balloon system directions for use (dfu) states "the maximum placement period for the orbera intragastric balloon system is 6 months, and it must be removed at that time or earlier.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Common Device Name: 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: 19610175
• Report Number: 3005099803-2024-02991
• Device Sequence Number: 8084928
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2025
• Device Model Number: B-4800
• Device Lot Number: AF05566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/15/2024
• Date Device Manufactured: 04/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male