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

Model Number B-50012

Device Problem Difficult to Remove (1528)

Patient Problems Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399)

Event Date 05/25/2023

Event Type  Injury  

Event Description

Healthcare professional reported difficulty with balloon removal resulted in injury to patient's esophagus.

Manufacturer Narrative

Combined medwatch submitted to the fda on 23/jun/2023.A review of the device labeling notes the following: risk review verbiage less last including labeling and monitoring.The current orbera365¿ intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "perforation" 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.1.Ensure that the patient has been on a liquid diet for 72 hours and npo (i.E.Nothing by mouth) for a minimum of 12 hours before attempting removal.Whether this regimen has been followed or not (i.E.In the case of an urgent removal), due to the potential for residual gastric contents in some patients, additional precautions for aspiration should be considered.In higher risk patients with signs and symptoms suggestive of severely delayed gastric emptying and/or gastric outlet obstruction, a focused physical examination for abdominal distension and/or succussion splash should be performed, followed by radiographic evaluation if succussion splash is absent and the epigastrium is full or tender.If radiographic evaluation is positive for distended stomach with or without an antral igb, then nasogastric decompression should be considered, the airway should be secured, and general anesthesia employed.2.Prepare the patient according to hospital protocol for sedation and endoscopy.Additionally, consider administering a smooth muscle relaxant such as intravenous glucagon to relax the esophageal sphincter.3.Insert the endoscope into the patient's stomach.4.Assess for the presence of food.If food is present in the stomach the procedure should be delayed.If emergent removal, the airway should be protected prior to proceeding.5.Get a clear view of the filled igb using the endoscope.6.Insert a sheathed needle catheter down the working channel of the endoscope.7.Use the advanced exposed needle to puncture the igb.8.Push the needle catheter through the igb shell and well into the igb.9.Remove the needle from the catheter.10.Apply suction to the deeply inserted catheter until all fluid is evacuated from the igb.11.Remove the catheter from the igb and out of the working channel of the endoscope.12.Insert a long jaw or wire prong grasper through the working channel of the endoscope.13.Grab the igb with the grasper (ideally at the opposite end of valve if possible).14.With a firm grasp on the igb, slowly extract the igb up the esophagus.15.When the igb reaches the upper esophageal sphincter, hyperextend the head to straighten the passage out of the esophagus and throat, allowing for an easier extraction.16.Remove the igb from the mouth.Possible adverse events associated with the use of the igb include: intestinal obstruction by the igb.An insufficiently filled igb or a leaking igb that has lost sufficient volume may be able to pass from the stomach into the small bowel.It may pass all the way into the colon and be passed with stool.However, if there is a narrow area in the bowel or adhesion formation, which may occur after previous surgery on the bowel, the igb may not pass and could cause a bowel obstruction.If this occurs, surgery or endoscopic removal could be required.Esophageal obstruction.When the igb is being filled in the stomach, the igb could be inadvertently pulled back into the esophagus.This can cause rupture of the esophagus.If this occurs, surgery or endoscopic removal could be required.Gastric outlet obstruction.A partially filled igb (i.E.,<400cc), or a leaking igb could lead to gastric outlet obstruction, requiring igb removal.It is also possible for a fully filled (400 700cc) igb to impair the gastric outlet, which can produce a mechanical impediment to gastric emptying.Gastric outlet obstruction may require early removal.Injury to the digestive tract during placement of the igb in an improper location such as in the esophagus or duodenum.This could cause bleeding and perforation, which could require a surgical or endoscopic correction for control.Continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach, delayed gastric emptying and/or the igb blocking the outlet of the stomach.It is even theoretically possible that the igb could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Injury to the lining of the digestive tract as a result of direct contact with the endoscope, the igb, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Additional information: the device was returned to the apollo device analysis laboratory on (b)(6) 2023.A deflated balloon with brown coloration was returned.The shell has been torn/ripped with 3 pieces of the shell shredded with jagged edges.The damaged shell has jagged edges from a surgical instrument for removal purposes.The complaint has been verified regarding difficulty in removing the balloon as the returned device shows evidence of being torn multiple places.The investigator determined that a device history record (dhr) review is required for this complaint, as this is a reportable event.Dhr was completed for lot number#: af04736.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#: af04736 and allegation.

• 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
• 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: 17191266
• MDR Text Key: 317750375
• Report Number: 3006722112-2023-00132
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020725
• UDI-Public: (01)10811955020725(17)20230916(10)AF04736
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2023

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 Expiration Date: 09/16/2023
• Device Model Number: B-50012
• Device Catalogue Number: B-50012
• Device Lot Number: AF04736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 63 KG