MAUDE Adverse Event Report: GI DYNAMICS ENDOBARRIER

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858); Pain (1994); Sepsis (2067); Chills (2191); Complaint, Ill-Defined (2331)

Event Date 01/14/2015

Event Type  Injury  

Event Description

I was in a clinical trial for the endobarrier from gi dynamics.It was inserted in my small intestine in (b)(6) 2014.I was informed of its safety because there was no incision involved.I felt bad immediately and informed them.I was told pain was normal.I went for my checkups as instructed.I followed their diet of 1500 calories per day.They took blood work on every visit.I started feeling very sick in (b)(6) 2014.I thought i had the flu.But it got worse over the next two weeks.I had fever and chills and my abdomen was hurting.On (b)(6), 2015 i felt like i was dying.I knew it couldn't be the flu.My wife called my doctor and dr (b)(6) who was in charge of the clinical trial.Dr (b)(6) said "i hope its not a liver abscess." this would be the first time we had ever heard of a liver abscess.I went on to my regular doctors appointment on (b)(6).I could not bare to touch my abdomen and my white blood cell count was very high.I was told to contact the clinical trial and dr (b)(6), we emailed my blood work to her.She finally called back late that evening and told me i should come to the emergency room.We drove the 1 1/2 drive the next morning on (b)(6).When i got there my white blood cell count was 15.5 my temperature was 103.They did ultrasounds and ct scans.I had a hepatic abcess the size of a fist on my liver.It was 7.5 x 6.1 centimeters.I also had sepsis.They hospitalized me immediately.The next morning (b)(6) the endobarrier was removed.Then later a drain was put into my liver.They pumped two bottles of infection from my abdomen.I was put on antibiotics.It would take nearly 5 days for the bacteria to grow in a petrie dish.I had strep anginosus.I then was referred to the infectious disease doctor.I was released on (b)(6) with the drain tube and a picc line.I would have to have my wife give me antibiotics daily (sash) for 6 weeks.I had a nurse every week for 6 weeks.I found out on (b)(6) that i was the 4th clinical trial patient to get a liver abscess.No one ever informed me that this was an issue.I should have been advised after the first.Then maybe i would have had some idea of what was happening to me and i could have caught it earlier.Why did they not check my blood work if this was a know issue? i was not formally informed until (b)(6) 2015 about this adverse event.This was nearly 2 months after i nearly died from it.In (b)(6) 2015 i went back for a clinical trial appointment and was asked to sign a consent from (b)(6) regarding the liver abscess.I refused! they had not paid my bills and i almost died.I didn't see the need because i no longer had the implant.When i refused to sign they told me they could no longer help me.I had to fight to get them to pay my medical bills.My personal insurance was billed.The fda halted the clinical trial after i got sick.Then 3 more people got an abscess.The clinical trial was shut down and everyone explanted in (b)(6) 2015.Now i find out that they are attempting to start a new trial.I want my information heard.How i was not informed of the adverse event, how i was fired from the trial for refusing to sign a consent from the adverse events.And how i had to fight for them to pay my medical bills.I thought i could help a lot of people with diabetes.I was told how safe it was.It almost killed me.And probably would have if my wife had not been so diligent with my care.

• Brand Name: ENDOBARRIER
• Type of Device: ENDOBARRIER
• Manufacturer (Section D): GI DYNAMICS
• MDR Report Key: 6375829
• MDR Text Key: 69142163
• Report Number: MW5068224
• Device Sequence Number: 1
• Product Code: PFE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LISINOPRIL. ; OTC MEDS: NONE. ; PAROXETINE; RX MEDS: METFORMIN
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 46 YR
• Patient Weight: 107