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 Death (1802); Dyspnea (1816); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Vomiting (2144); Cramp(s) (2193); Malaise (2359)

Event Date 08/01/2019

Event Type  Death  

Manufacturer Narrative

A copy of the autopsy report was requested from the initial reporter.To date, the report has not been received by apollo.A review of the device 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.Death due to complications related to gastric or esophageal perforation is possible.Necrosis is identified under table 13.Orbera¿ device- and procedure- related adverse events and complaints reported through clinical product surveillance 1 between january 1, 2008 and january 31, 2019 noting 13 patients have experienced this event.

Event Description

Reported as: a patient with the orbera intragastric balloon had "back pain and stomach cramping.[patient] was tolerating clear liquids with minimal vomiting.[physician] sent in prescription for levsin as per our standard.No other c/o that day.[nurse] called to check on [patient] the next day and [patient's spouse] answered the phone and informed me that [patient] had passed away last night.[patient's spouse noted patient] was lethargic and not feeling great that evening.Was c/o shortness of breath.[spouse] looked over at one point and noticed [patient] wasn't breathing.[spouse] called 911 and they instructed to start chest compressions.[spouse] says some bloody fluid came out of [patient's] mouth but [patient] never regained a pulse." additional information noted: "cause of death was gastric perforation." additional information received from the placement physician: the patient had an uneventful post-procedure recovery.Later that next day [the patient] had some difficulties with nausea, had a small emesis of clear material, and had some cramping.Levsin was prescribed for the cramping.That evening the physician called and spoke to the [spouse].[the patient's spouse] said [patient] was still feeling poorly and had taken to bed but offered no different or new complaints.The next day the nurse practitioner called but received no answer.Called again and the [spouse] answered and notified her of the patient's death.The medical examiner called the physician and told him that there was a perforation along the lesser curve, @1200 of dark brown gastric fluid in the abdomen, an intact balloon weighing 612 gm, consistent with a 600 cc fluid filled balloon and advanced nash changes involving the liver.Update from the physician who spoke to the medical examiner, "perforation was 5 cm distal to the gej and consistent with pressure necrosis.There were several serosal areas of evolving injury.Histology reveals necrosis only, no other underlying pathology.Since there was large (subjectively described) emesis during resuscitation and over a liter of gastric contents in the abdominal cavity.This is consistent with gastric distention with a large volume of retained fluids and subsequent perforation.

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on (b)(6) 2020.Device summary evaluation: the device was returned to the apollo device analysis laboratory on (b)(6) 2019.The inflated balloon was received with the paperwork and disk.The balloons saline was clear in appearance and there were no unknown particles on the shell.The returned balloon was visually inspected by engineering and there were no abnormalities observed.Response to fda request is attached as "attachment 1".- attachment: [response to fda request for additional information (b)(6) 2019).Pdf.

Manufacturer Narrative

Supplement #2 - medwatch sent to fda on (b)(6) 2020.Additional information: d10 pathologist reported, "the slides in this case do not support ischemic injury as the mechanism of perforation.The process in this case is very acute, with only a scant neutrophilic infiltrate in a few areas, which is also not typical of ischemic perforation.The findings are compatible with rupture of an acutely grossly distended stomach but are not specific for that pathogenesis."aa.

• 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: 8942327
• MDR Text Key: 155934173
• Report Number: 3006722112-2019-00148
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: B-4800
• Device Catalogue Number: B-4800
• Device Lot Number: AF02770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASA 81MG.; DECADRON.; EMEND.; LEVOTHYROXINE.; LEVSIN.; PANTOPRAZOLE.; PROPOFOL.; XANAX.; ZOFRAN.
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 121