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

Model Number	B-4800
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code: a1406: captures the reportable event of inflation problem.Impact code f2202: captures the reportable event of endoscopy procedure.
Event or Problem Description
It was reported to boston scientific corporation that an orbera intragastric balloon system was implanted on an unknown date for weight loss.After the procedure, the patient started to experience discomfort and pain.The patient had an endoscopy procedure on (b)(6) 2023, and had theorbera intragastric balloon system was explanted.It is noted that the patient has fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that an orbera intragastric balloon system was implanted on (b)(6) 2023 for weight loss.After the procedure, the patient started to experience discomfort and pain.The patient had an endoscopy procedure on (b)(6) 2023 and had the orbera intragastric balloon system was explanted.It is noted that the patient has fully recovered.**additional information **** the explant date is (b)(6) 2023.
Additional Manufacturer Narrative
Block h6: device code: a1406: captures the reportable event of spontaneous inflation problem.Impact code f2202: captures the reportable event of additional endoscopic procedure.Block a1, block a2, block a4, block b3, block b5, and block d6 have been updated based on additional information received on december 7, 2023 and december 14, 2023.Corrected content previously provided in block b5, block d4, block g2, and block h6.
Additional Manufacturer Narrative
Block h6: device code: a1406: captures the reportable event of spontaneous inflation problem.Impact code f2202: captures the reportable event of additional endoscopic procedure.Block a1, block a2, block a4, block b3, block b5, and block d6 have been updated based on additional information received on december 7, 2023 and december 14, 2023.Corrected content previously provided in block b5, block d4, block g2, and block h6 block h10: investigation summary: with all the available information boston scientific concludes that the reported event was unable to be confirmed, as the balloon was returned deflated with a large slit on the shell with jagged edges.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the balloon was returned deflated.There is a large slit on the shell with jagged edges.Risk review; a risk review of the orbera was completed and confirmed that the event of balloon spontaneous inflation, discomfort, pain and endoscopic procedure were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: a labeling review was performed on the device instructions for use (ifu) and it was determined that the ifu does address the balloon spontaneous inflation, discomfort, and pain like adverse events of the device.There is no evidence of a device misuse at the information provided in the complaint.Investigation conclusion: for the as reported balloon spontaneous inflation, discomfort, and pain these adverse events are known and documented in the labeling and all reasonable steps have been taken, for this reason these events are catalogued as known inherent risk of device.The slit on the shell was most likely caused by the instruments used to remove the balloon.Therefore, it is classified as adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.The endoscopic procedure cannot be replicated in the laboratory and it will be closed as no problem detected.Based on all gathered information, boston scientific concludes that the reported event was unable to be confirmed and assigns an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that an orbera intragastric balloon system was implanted on (b)(6) 2023 for weight loss.Following the procedure, the patient started to experience discomfort and pain after the orbera balloon spontaneously inflated.The patient underwent an endoscopy procedure on (b)(6) 2023 to explant the orbera intragastric balloon system.It is noted that the patient has fully recovered.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Common Device Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 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: 18284630
• Report Number: 3005099803-2023-06589
• Device Sequence Number: 12452899
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2024
• Device Model Number: B-4800
• Device Lot Number: AF05103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 03/22/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/04/2024; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 116 KG