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

Model Number B-4800

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

Patient Problems Erosion (1750); Cardiac Arrest (1762); Dehydration (1807); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Pulmonary Edema (2020); Septic Shock (2068); Vomiting (2144); Hypernatremia (2242); Peritonitis (2252); Obstruction/Occlusion (2422); Respiratory Failure (2484)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

The reporter of the event was asked to return the product for analysis.It was indicated the device was discarded.Further follow up has been conducted with the reporter regarding the patient's current condition.A review of the labeling notes the following: precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain.Patients will need to immediately contact their physician for any severe or unusual symptoms.Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping.Food digestion may be slowed during this adjustment period.These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications.Typically the stomach acclimates to the presence of the device within the first 2 weeks.In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera placement).Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms.The physiological response of the patient to the presence of orbera¿ 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.Patients need to be evaluated and the device removed at or within 6 months of placement.Clinical data does not exist to support use of an individual orbera beyond 6 months.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications: possible complications of the use of orbera¿ include: 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, delayed gastric emptying and/or 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.Abdominal or back pain; either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Serious adverse events observed in global product experience with orbera¿ and from literature reviews, but not seen in the u.S.Clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death.The event of dehydration was reported in the us (b)(6) clinical study and was experienced by 14.4% of the labeling.

Event Description

Reported as: a patient with the orbera intragastric balloon had been experiencing nausea, vomiting and chest pain for six days.The patient spoke to the physician and the physician recommended they go to the hospital to get iv fluid as the patient was dehydrated.The patient was admitted to the hospital due to gastric outlet obstruction.Patient had an endoscopy and ct scan, which noted small bleeding erosions in the stomach.The physician removed the device and it was observed the patient had peritonitis and three perforations on the anterior portion of the stomach 3-5 millimeters in length and 3 cm away from each other.It was noted the patient went into septic shock secondary to the perforations.The patient went into cardiac arrest and was placed in the icu where the patient was noted to be in unstable condition.

Event Description

Further information received from hospital discharge records: patient discharged home after fourteen days in hospital.Patient did not have a history of congestive heart failure.Additional information received noted patient was treated during hospital stay for acute pulmonary edema, hypernatremia and brief acute respiratory failure.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 20/nov/2018.

• 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
• MDR Report Key: 7985268
• MDR Text Key: 124357804
• Report Number: 3006722112-2018-00262
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF01951
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALENDRONATE; AMITRIPTYLINE; BUPROPION; CARREDILOL; CLONAZEPAM; DEXTROAMPHETAMINE-AMAMPHETAMINE; ESZOPICLONE; ETODOLAC; EZETIMIBE; FOSAMAX PLUS; HYOSCYAMINE; LATUDA; LOSARTAN; NAPROXEN; OMEPRAZOLE; ONDANSECTRON; PHENTERMINE; PRILOSEC; QUETIAPINE; ROSUVASTATIN; SPIRONOLACTONE; TRAMADOL; VALSARTAN; ZOLPIDEN; ALENDRONATE; AMITRIPTYLINE; BUPROPION; CARREDILOL; CLONAZEPAM; DEXTROAMPHETAMINE-AMAMPHETAMINE; ESZOPICLONE; ETODOLAC; EZETIMIBE; FOSAMAX PLUS; HYOSCYAMINE; LATUDA; LOSARTAN; NAPROXEN; OMEPRAZOLE; ONDANSECTRON; PHENTERMINE; PRILOSEC; QUETIAPINE; ROSUVASTATIN; SPIRONOLACTONE; TRAMADOL; VALSARTAN; ZOLPIDEN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR