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

Model Number B-4800

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Abdominal Distention (2601)

Event Date 06/05/2022

Event Type  malfunction  

Event Description

Sixty nine year old male, history of diabetes, hypertension, hypercholesterolemia, had the balloon place a month ago.Patient was seen in the office (b)(6) everything was okay, doing great with diet and water intake.Sunday according to the patient's husband the patient had experienced 3 days prior constipation but passing gas, no nausea or vomiting.They called the office service line on sunday morning reporting the patient had been vomiting 20 to 30 times.The patient was instructed to take their anti-nausea medication and felt better.Late sunday afternoon the office was contacted again.Patient was now experiencing bloating, distension, and pain and were able to speak with one of the partners.The patient was instructed to go to the emergency room at (b)(6).The emergency room folks triaged the patient as alert, awake with abdominal distension and pain.Patient then began to experience of shortness of breath, tachycardia and became hypotensive.Emergency room notified dr.(b)(6) the patient was in shock.Dr.(b)(6)rushed over to the facility where the patient had now been intubated.Abdominal x-ray had been taken but didn't show definitive free air.Emergency room wanted to take him to do ct scan, but the patient coded.Treated with "levo", "neuro", "vaso" and patient responded.Wanted to take patient to operating room for exploratory, patient had a thready pulse, critical care doctor from icu kept working on patient who then coded a second time.Patient was maxed out on "levo" started "epi".Patient needed to go to operating room but unless he was stable, they couldn't take him.Husband was consulted and asked that they do everything they could do but if he coded a third time to let him go.Iv fluids continued and further epi given, pulse thready, the patient experienced a third code and was pronounced.Dr.(b)(6) has no idea if an autopsy will be performed, likelihood a perforation, the presentation was fast.When asked further about medications the husband said the patient had been taking his protonix as directed.Additional medication the patient was taking; metformin, glyburide, metoprolol, lisinopril, hctz (on hold for orbera therapy), atorvastatin, advair, dutasteride and amlodipine.Additional details provided.Male patient (b)(6), date of birth (b)(6) 1953.Starting wt.275 lbs.,1/jun/22 wt.255 lbs.Date of orbera placement (b)(6) 2022.Date of death (b)(6) 2022.

Manufacturer Narrative

Initial medwatch submitted to the fda on 17/jun/2022.A review of the device labeling notes the following: the current orbera¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "intolerance, vomiting, reflux and early removal" as follows: the igb is composed of a soft silicone elastomer and is easily damaged by instruments or sharp objects.The igb must be handled only with gloved hands and with the instruments recommended in this document.Each physician and patient should evaluate the risks associated with endoscopy and intragastric balloons (see complications below) and the possible benefits of a temporary treatment for weight loss prior to use of the orbera¿ system.To prevent ulcers and control gastroesophageal reflux symptoms, it is recommended that the patient start a program of oral proton pump inhibitors (ppis) for approximately 3-5 days prior to igb placement so a maximal gastric acid suppression effect will be present on the day of placement.It is recommended that the ppi dose be given sublingually after igb placement if nausea and/or vomiting are present.A starting full dose daily regimen of an oral ppi should be continued as long as the igb is in place.Other medications that are started prophylactically should be continued after igb placement until they are no longer needed.Furthermore, subjects will be directed to avoid medications known to cause or exacerbate gastroduodenal mucosal damage.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.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, acute pancreatitis, spontaneous inflation, ulceration, gastric and esophageal perforation, and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Possible complications of the use of the orbera¿ system include: death due to complications related to intestinal obstruction, gastric perforation, is possible.Pregnancy or breast-feeding contraindicates use of this device.Should pregnancy be confirmed at any time during the course of treatment, the device should be removed as soon as it is safely 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.Spontaneous over inflation of an indwelling balloon with symptoms including intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care.Patients with an igb that present with severe abdominal pain that have a negative endoscopy and x-ray may additionally require a ct scan to definitively rule out a perforation.Note that continued nausea and vomiting could result from direct irritation of the lining of the stomach, as a result of the balloon blocking the outlet of the stomach, or hyperinflation of the balloon.Additional information: the device has not been returned for analysis.The investigator is waiting until the lot number of the device is known to determine whether a device history record (dhr) review is or is not required for this complaint.

• Brand Name: ORBERA¿ INTRAGASTRIC BALLOON SYSTEM
• Type of Device: INTRAGASTRIC BALLOON SYSTEM
• 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, cs CRI ; CS CRI
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 14738502
• MDR Text Key: 295812663
• Report Number: 3006722112-2022-00056
• Device Sequence Number: 1
• Product Code: LTI
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

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
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/17/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 116 KG