MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Device Slipped (1584)

Patient Problems Erosion (1750); Dehydration (1807); Inflammation (1932); Irritation (1941); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Vomiting (2144); Ulcer (2274); Obstruction/Occlusion (2422); Blood Loss (2597)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was captured in a literature article published in june 2018.Further information has been requested with one of the authors to obtain additional information such as implant date, explant date, physician, patient information, and device information.To date, apollo has not been able to obtain further information.Device labeling addresses the event as follows: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications which may result from the use of this product include the risks associated with the medications and methods utilized in the surgical procedure, the risks associated with any surgical procedure and the patient's degree of intolerance to any foreign object implanted in the body.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.Nausea and vomiting may also be symptoms of stoma obstruction or a band/ stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.Other adverse events considered related to the lap-band® system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.Warnings: patients should be advised that the lap-band system is a long-term implant.Explant (removal) and replacement surgery may be indicated at any time.Medical management of adverse reactions may include explantation.Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction.

Event Description

Reported event from journal article titled: " 'black esophagus' and gastric volvulus following slipped laparoscopic adjustable gastric band", obesity surgery.Reported as: "patient presented to the emergency department with a 16-h history of severe nausea and abdominal pain.Patient was noted to be in moderate distress, tachycardic with mild abdominal distension and epigastric tenderness.[patient] was admitted to the plastic surgery service for hydration, pain control, and monitoring.Upon evaluation, [patient] was in moderate distress with repetitive vomiting.Plain abdominal radiographs revealed that the band was in an abnormal position and demonstrated the classic "o" sign consistent with a slipped band.An upper endoscopy was performed, which demonstrated near confluent black esophageal mucosa from its middle third to the gastro-esophageal junction." the physician spoke to the patient and noted "gastric obstruction from possible gastric volvulus due to the slipped band, the gangrenous esophageal mucosa, and risk of perforation with transmural involvement.Exploration revealed a moderate amount of hemorrhagic peritoneal fluid in the upper abdomen which was evacuated.The gastric body was grossly ischemic due to an organo-axial volvulus secondary to the band which had slipped to the level of the antrum.One week after presentation repeat endoscopy showed significant improvement in the esophageal mucosal necrosis with areas of re-epithelialization and healing gastric erosions.Three weeks after following discharge, repeat endoscopy showed complete resolution of esophageal mucosal necrosis.".

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7701090
• MDR Text Key: 114405148
• Report Number: 3006722112-2018-00177
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR