MAUDE Adverse Event Report: APOLLO ENDOSURGERY ORBERA INTRAGASTRIC BALLOON

Lot Number 0091904

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

Patient Problem Death (1802)

Event Date 07/31/2019

Event Type  Death  

Event Description

Pt had orbera balloon placed on (b)(6) 2019.She tolerated procedure well.I spoke with her that night (b)(6) and again the next day and she had expected side effects from the balloon including some nausea with minimal vomiting of clear liquid, abdominal and back discomfort, and cramping.Physician was notified of above.Pt instructed to take tylenol every 4 hrs as needed, use heating pad, take warm bath and levsin sent in for cramping and pt instructed on use.When i called on (b)(6) 2019 to check on her, her husband informed me she had passed away during the night and autopsy would be done.Original form filled out was the voluntary medical device complaint.This was the form i was instructed to fill out.I just received info that the mandatory form would now be done as well.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: ORBERA
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 9197427
• MDR Text Key: 162690740
• Report Number: 9197427
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0091904
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Distributor Facility Aware Date: 08/02/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 121