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

Model Number N/A

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

Patient Problem Abdominal Pain (1685)

Event Date 12/03/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 12/29/2015.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.The reporter stated the device would not be returned, and to date apollo has not received any further device information.Device labeling addresses the reported event as follows: 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.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.A feeling of heaviness in the abdomen.Abdominal or back pain, either steady or cyclic.

Event Description

Reported as: the patient had the orbera intragastric balloon removed due to complaint of "severe cramping.".

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 02/05/2016.

• Brand Name: ORBERA INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5333452
• MDR Text Key: 34638599
• Report Number: 3006722112-2015-00600
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020619
• UDI-Public: 10811955020619
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: Physician
• Device Expiration Date: 04/01/2017
• Device Model Number: N/A
• Device Catalogue Number: B-4800
• Device Lot Number: RWAP6396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2015
• 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
• Treatment: LEVSIN
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 97