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

Model Number B-4800

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

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

Further follow up has been conducted with the reporter to see when the device will be removed.Device labeling addresses the reported event as follows: warnings: endoscopic removal of orbera¿ must be completed in the presence of an empty stomach.Patients should be on a liquid diet for 48 hours and npo for a minimum of 12 hours prior to removal.If food is found in the stomach upon endoscopic examination, then measures (aspiration of stomach contents, endotracheal intubation, or delay of procedure) must be taken to protect the airway.The risk of aspiration of gastric contents into the patient's lungs represents a serious risk which can result in death.

Event Description

Reported as: a patient with the orbera intragastric balloon "went to have balloon removal.It was observed the patient had too much fluid in the stomach, so surgery was aborted.As the physician removed the scope, the patient aspirated." patient was hospitalized for three days and was then released and doing better.The device remains implanted.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8035480
• MDR Text Key: 126066389
• Report Number: 3006722112-2018-00293
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

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 Expiration Date: 09/26/2019
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF01325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 90