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

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

Patient Problems Cardiac Arrest (1762); Death (1802); Fever (1858); Pneumonia (2011); Septic Shock (2068); Vomiting (2144); Malaise (2359); Coma (2417)

Event Date 09/21/2017

Event Type  Death  

Manufacturer Narrative

The reporter of the event was asked if the product was available for analysis and to provide device information.To date, apollo has received confirmation from the author that the device manufacture is unknown.Further information has been requested of the reporter regarding: implant date, explant date, date of death, date of occurrence, and additional patient information.To date, no additional information has been received by apollo.A review of the labeling notes the following: warnings and precautions: the physiological response of the patient to the presence of the orbera system balloon may vary depending upon the patient's general condition and the level and type of activity.The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications - possible complications of the use of the orbera® system include: death due to complications related to intestinal obstruction is possible.Gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.

Event Description

Literature review; "case report: an autopsy case of misdiagnosed wernicke's syndrome after intragastric balloon therapy" author vellante et al 2018.Reported as: seven months after the igb placement, the patient arrived at the emergency unit complaining of fever, cough, lower limb asthenia, and general malaise.Patient was diagnosed with bronchial pneumonitis, and antibiotic therapy was prescribed.The patient was then discharged and sent to be followed up by general practitioner.The igb was removed 1 month later (i.E., it remained in situ for 8 months since its placement).After a week, the patient was admitted to the hospital for asthenia, memory deficit, and progressive worsening of general malaise.During this hospitalization, the patient's relatives reported a history of vomiting that was correlated with food intake and that had started soon after the igb placement.It then appeared to worsen from the fourth month after the igb placement.Moreover, the relatives reported a diagnosis of relatively unspecified peripheral neuropathy.The patient then contracted severe nosocomial pneumonia, and soon progressed into septic shock.After an episode of cardiac arrest, the patient was transferred to the intensive care unit, while in a coma.A consultant neurologist hypothesized wernicke's syndrome at the origin of the illness.Eight days later, the patient was declared brain death.Initial follow-up with the author of the article indicates the manufacturer of the device is unknown.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

• 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, costa rica ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7805030
• MDR Text Key: 117866024
• Report Number: 3006722112-2018-00227
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 51 YR