MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA 365 INTRAGASTRIC BALLOON

Model Number B-50012

Device Problem Inflation Problem (1310)

Patient Problems Fever (1858); Failure of Implant (1924)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 28/aug2023.A review of the device labeling notes the following: the current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of inflation, fever and early removal.As follows: the orbera365¿ intragastric balloon (igb)system filled to 400cc and 700cc with uninflated system in the foreground."the physiological response of the patient to the presence of the orbera365¿ 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." "warnings" each patient must be monitored closely during the entire term of treatment in order to detect the development of possible adverse events.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, igb inflation after placement (i.E.Spontaneous hyperinflation), ulceration, gastric and esophageal perforation, and other adverse events 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.Spontaneous hyperinflation of an indwelling igb with gas has been reported in patients with an indwelling igb.Symptoms of significant igb over-inflation include intense abdominal pain, swelling of the upper abdomen (abdominal distension) with or without discomfort, difficulty breathing, gastroesophageal reflux, nausea and/or vomiting.Patients experiencing any of these symptoms should be counseled to seek immediate care and should be evaluated for hyperinflation, particularly when persistent abdominal pain, abdominal distension, and food intolerance occur beyond the initial accommodative period of the igb.Plain radiographic films will often demonstrate hyperinflation with a large air-fluid level within the igb and an increase in igb volume compared to the original volume.Hyperinflation of the igb often warrants its early removal to prevent serious complications such as gastric outlet obstruction and contact ulceration.Because hyperinflation increases the internal pressure of the igb (due to accumulated gas) and may increase the fragility of the igb wall, there is an increased risk of rupture followed by the sudden forceful release of gas and fluid contents when it is punctured or endoscopically manipulated.Therefore, it is suggested that the patient's airway is protected with endotracheal intubation prior to endoscopic removal in order to prevent pulmonary aspiration of the balloon contents.Additionally, in situations in which controlled balloon aspiration is done, it is recommended that mid-stream fluid aspirated from the balloon is sent for bacterial and fungal cultures.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.The igb is composed of 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.Gastroesophageal reflux.A feeling of heaviness in the abdomen.Acute pancreatitis.Spontaneous hyperinflation due to gas production within the igb.Abdominal or back pain, either steady or cyclic." caution: fill the igb with sterile saline.An aseptic technique, similar to changing iv fluids (e.G.Use of clean or sterile gloves, sterile syringe, etc.), is recommended.Though the cause of hyperinflation is unknown, it may be caused by fungal or bacterial microbes contaminating the balloon.One recommended mitigation is to avoid contaminating the saline within the balloon with microorganisms that may lead to spontaneous hyperinflation.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.Dhr review was completed for lot number, af04909.The subject product met all specifications and requirements in effect at the time of manufacture. there are no other complaints against this lot number, af04909 and allegation. .

Event Description

Healthcare professional reported the decision to explant was made when the patient presented with fever.The balloon was determined to be inflated and decomposes into pieces when removed with extraction forceps.Balloon was successfully explanted.

Manufacturer Narrative

Supplement 01 medwatch submitted to the fda on 30oct2023.Device evaluation summary: the device was not returned.Assessment of the device involved in this complaint was not possible, and it has not been possible to determine the root cause for this event.The user effect of inflation, fever and early removal are known and labeled possible adverse event.Correction initial mw report filed incorrectly with mfr report #: 3006722122-2023-00165.Correct mfr report #: is 3006722112-2023-00165.

• Brand Name: ORBERA 365 INTRAGASTRIC BALLOON
• Type of Device: INTRAGASTRIC BALLOON
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, tx 78746 ; CS 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 17634360
• MDR Text Key: 322091622
• Report Number: 3006722122-2023-00165
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20240214(10)AF04909
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2024
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 59 KG