MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. ORBERA365¿ INTRAGASTRIC BALLOON SYSTEM

Model Number B-50012

Device Problems Inflation Problem (1310); Mechanical Problem (1384)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 06/jul/2022.The current orbera intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "broken / damaged / defective component and expired product" are as follows: precautions if difficulty with the igb placement catheter is noted during placement (e.G., resistance to igb filling), then the device should be removed and replaced with a new igb.To lessen, or prevent catheter defects, the catheter must remain slack during the filling process.If the catheter is under tension during this process, the tip of the catheter may dislodge from the igb, preventing further igb deployment.Warnings and precautions: proper positioning of the placement catheter assembly and the orbera intragastric balloon system within the stomach is necessary to allow proper inflation.Lodging of the balloon in the esophageal opening during inflation may cause injury and/or device rupture.The orbera intragastric balloon system is composed of soft silicone elastomer and is easily damaged by instruments or sharp objects.The balloon must be handled only with gloved hands and with the instruments recommended in this document.If the balloon becomes separated from the sheath prior to placement, do not attempt to use the balloon or reinsert the balloon into the sheath.During the filling process the fill tube must remain slack.If the fill tube is under tension during the intubation process, the fill tube may dislodge from the balloon, preventing further balloon deployment.Warning: patients must be advised that the igb is intended to be placed for 6 months maximally, at which point removal is required.Longer periods of igb placement increase the risk of igb deflation (a reduction in size of the device due to loss of saline) which can lead to intestinal obstruction and risk for death.The risk of these events is also significantly higher when igbs are filled to a larger volume than indicated (greater than 700cc).Warning: when filling the igb during the placement procedure, avoid rapid fill rates as these will generate high pressure which can damage the igb valve or cause premature detachment of the igb from the tip of the placement catheter.Additional information: the facility used an expired product to removed the balloon.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.

Event Description

Patient went in to have the balloon removed at the scheduled time for removal.During the removal process, the doctor noticed that the needle grasper tool was expired but still used the tool to extract the balloon and during use the tool malfunctioned.The balloon was removed successfully and the patient is doing well.

Event Description

Patient stated the following symptoms: pain, vomiting and intolerance.She couls only tolerate intake of water.

Manufacturer Narrative

Supp 1 medwatch submitted to the fda on 21/jul/2022.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 and early removal.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 device has not been returned for analysis.A device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number af03785.

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on 26/sept/2022.A device history record (dhr) review was performed for reporting purposes.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number af03785.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 18/july/2022.A deflated balloon with light brown coloration was returned for evaluation.An air leak test was conducted, and the shell slowly deflated due to a small slit on the shell.Under microscopic analysis, the small slit has jagged edges which is consistent with a surgical instrument for removal purposes.The valve was submerged in water and there were bubbles coming from the valve.Under microscopic analysis, there is unknown particles present inside the slit valve.The complaint has been verified as more than likely the unknown particles prevented proper closer of the slit valve.Lab analysis was able to replicate the reported event of "inflation", as the valve leaked.The user effect of "inflation" is known and labeled possible adverse event.

• Brand Name: ORBERA365¿ 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: 14934788
• MDR Text Key: 304295098
• Report Number: 3006722112-2022-00068
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20220721(10)AF03785
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF03785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2020
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 89 KG