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

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

Patient Problems Death (1802); Dyspnea (1816); Nausea (1970); Vomiting (2144); Lethargy (2560); Bowel Perforation (2668)

Event Date 08/01/2019

Event Type  Death  

Event Description

Pt had the orbera intragastric balloon placed on (b)(6) 2019.She tolerated the procedure well.That night and the next day she had typical complaints post balloon placement of nausea, some vomiting of clear fluid, back discomfort / pain and abdominal cramping.She reported tolerating clear liquids for the most part and having light yellow urine.No other complaints on the afternoon of (b)(6) 2019.Sent in prescription for levsin per standard post procedure orders and notified the physician.When i called to check on her the next day (b)(6) 2019 her husband answered and informed me she had passed away during the night.He said she was lethargic and had complained of shortness of breath.He later realized she was not breathing and called 911.According to him, the paramedics were not able to resuscitate her.Autopsy done and cause of death determined to be gastric perforation.Fda safety report id# (b)(4).

• Brand Name: ORBERA
• Type of Device: IMPLANT, INTRAGASTRIC, FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC. ; austin TX 78746
• MDR Report Key: 8892620
• MDR Text Key: 154400425
• Report Number: MW5088989
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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