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

Model Number B-50012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pyrosis/Heartburn (1883); Nausea (1970); Vomiting (2144)

Event Date 09/30/2023

Event Type  Injury  

Manufacturer Narrative

Block h6 impact code: f2022 endoscopic procedure captures the reportable event.Impact code: f08 hospitalization captures the reportable event.A4: patient weight at explant 70kg, patient weight at implant 77kg.

Event Description

It was reported to boston scientific corporation that the patient had an orbera365 intragastric balloon system implanted on 08sep2023.After the procedure, the patient started experiencing nausea and vomiting on (b)(6) 2023.The patient went to the er and an egd was performed; the egd showed the patient had a few gastric erosions and reflux esophagitis.The balloon was intact and located in the body.The patient was admitted to the hospital for observation where they received nutrition and fluid support.Due, to intermittent nausea and vomiting, the patient elected to have the balloon explanted on (b)(6) 2023.The patient is stable once the balloon was removed, and the patient was discharged on (b)(6) 2023.

Manufacturer Narrative

Block h6: impact code: f2022 endoscopic procedure captures the reportable event.Impact code: f08 hospitalization captures the reportable event.A4: patient weight at explant 70kg, patient weight at implant 77kg.Correction: a2: patient dob.G4: 510k ce mark only.

Event Description

It was reported to boston scientific corporation that the patient had an orbera365 intragastric balloon system implanted on (b)(6) 2023.After the procedure, the patient started experiencing nausea and vomiting on (b)(6) 2023.The patient went to the er and an egd was performed; the egd showed the patient had a few gastric erosions and reflux esophagitis.The balloon was intact and located in the body.The patient was admitted to the hospital for observation where they received nutrition and fluid support.Due, to intermittent nausea and vomiting, the patient elected to have the balloon explanted on (b)(6) 2023.The patient is stable once the balloon was removed, and the patient was discharged on (b)(6) 2023.Additional information: the patient had an (ugi) upper gastrointestinal series done which revealed the ballon caused a partial gastric obstruction, but contrast agent could flow through.

Event Description

It was reported to boston scientific corporation that the patient had an orbera365 intragastric balloon system implanted on (b)(6) 2023.After the procedure, the patient started experiencing nausea and vomiting on (b)(6) 2023.The patient went to the er and an egd was performed; the egd showed the patient had a few gastric erosions and reflux esophagitis.The balloon was intact and located in the body.The patient was admitted to the hospital for observation where they received nutrition and fluid support.Due, to intermittent nausea and vomiting, the patient elected to have the balloon explanted on (b)(6) 2023.The patient is stable once the balloon was removed, and the patient was discharged on (b)(6) 2023.

Manufacturer Narrative

Block h6 impact code: f2022 endoscopic procedure captures the reportable event.Impact code: f08 hospitalization captures the reportable event.A4: patient weight at explant 70kg, patient weight at implant 77kg.Correction: a2: patient dob, g4: 510k ce mark only.Additional information: d4 lot number, d4 expiration date, h4 manufacture date.

• 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: 18478064
• MDR Text Key: 332461283
• Report Number: 3005099803-2023-07131
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

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
• Device Operator: Health Professional
• Device Model Number: B-50012
• Device Lot Number: AF05487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/11/2024; 03/20/2024
• Supplement Dates FDA Received: 02/07/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• 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): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG