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

Lot Number 19816754

Device Problem Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Death (1802); Edema (1820); Fatigue (1849); Inflammation (1932); Nausea (1970); Pain (1994); Sepsis (2067); Dizziness (2194); Abdominal Distention (2601)

Event Date 04/24/2016

Event Type  Death  

Event Description

I am writing on behalf of my mother.She had the orbera balloon placed on (b)(6) 2015.From this point, up until her death, our experience was rather traumatic and includes many details but i will give a brief overview.Thirteen days after placement she had a pulmonary embolism and spent 4 days in icu.Prior to this, she was very healthy other than blood pressure issues, was very active, loved to travel, and was an elementary school counsellor.She was discharged home after p.E.On xarelto at which point i feel as though balloon should ve been removed - but it was not.As the weeks went on she continued to get sicker with nausea, fatigue, dizziness - so much so that she couldn't function in the mornings while trying to get ready for work.She called the office that placed the balloon - they continued to explain this was all normal and they repeatedly called in meds for nausea.She started having to miss work because she was so weak and dizzy.She wasn't able to eat but 2 bites of food even 4 months after the procedure.Finally on (b)(6) 2016 she was taken by ambulance to the er.Her liver enzymes were extremely elevated.Further testing showed edema around the gallbladder.Stomach debris and distention.On (b)(6) - she began to complain of severe abdominal pain and back pain - the dr said they needed to check her for pancreatitis.Before they were able to do so she became septic and was rushed to icu.During this time her liver enzymes continued to rise and she also needed dialysis.On approx.(b)(6) 2016, they removed the balloon.The surgeon said he had a hard time getting to it b/c there was so much food in her stomach that had not digested and that the balloon had food stuck to it that he had to remove.He said this was not typical for the removal process and that there should not be undigested food stuck to the device.On (b)(6) - she was transferred to another hospital out of state b/c she needed 24 hour dialysis at this point.On (b)(6) she transferred to (b)(6) hospital for a possible transplant but her body continued to get sicker and she passed away there on (b)(6) 2016 - 6 months after the balloon procedure.We feel this device caused some serious digestive issues to occur with obstruction, etc and per her medical records pancreatitis was also noted.We have contacted lawyers regarding this matter and haven't gotten anywhere b/c don't have any knowledge regarding the orbera and how dangerous it truly is.Something about that needs to change.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 7285472
• MDR Text Key: 100673095
• Report Number: MW5075363
• 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: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Device Lot Number: 19816754
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 62 YR
• Patient Weight: 78