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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Regurgitation (2259)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Further information has been requested of the initial reporter regarding: device information, clarity on the reported event, physician information, and additional patient information.To date, no additional information has been received by apollo.A review of the labeling notes the following: 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 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 as: a patient with the lap-band system was reported to have "problems with swallowing and food and water coming back up and evidentially nothing staying down and coughing continually, nothing helping for the problems.Had band unfilled, still didn't help." patient had to have surgery to have it removed."slowly recovering, then after surgery developed a pe blood clot in the lungs - slowly recovering.".

Manufacturer Narrative

Unknown taper type.Supplement #1 - medwatch sent to the fda on 20/dec/2018.Device labeling addresses the reported events as follows: esophageal distension or dilatation has been infrequently reported.This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction.It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility.Deflation of the band is recommended if esophageal dilatation develops.A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.

Event Description

Further information provided by a health professional noted the patient experienced nausea, reflux and mild distention of the esophagus.

• 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
• MDR Report Key: 8090998
• MDR Text Key: 127937585
• Report Number: 3006722112-2018-00296
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTIN; ELIQUIS; ESTROVEN; FIBER PILLS; GABAPENTIN 800MG; MULTIVITAMIN; PERCOCET 10/325 MG; TIZANIDINE 4MG; TYLENOL; ZYRTEC 10MG; BIOTIN; ELIQUIS; ESTROVEN; FIBER PILLS; GABAPENTIN 800MG; MULTIVITAMIN; PERCOCET 10/325 MG; TIZANIDINE 4MG; TYLENOL; ZYRTEC 10MG
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 116