MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP LARGE WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number AP LARGE

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

Patient Problems Muscle Spasm(s) (1966); Regurgitation (2259)

Event Date 02/26/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii medwatch sent to fda on (b)(6) 2016.The device will not be returned for analysis.Based on the serial number provided, it is assumed the connecter type associated with this event is a taper ii.Device labeling addresses possible outcomes of reflux and esophageal spasm as follows: adverse events: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.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.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.Warnings: some types of esophageal dysmotility may result in inadequate weight loss or in esophageal dilatation when the band is inflated and may require removal of the band.On the basis of each patient's medical history and symptoms, surgeons should determine whether esophageal motility function studies are necessary.If these studies indicate that the patient has esophageal dysmotility, the increased risks associated with band placement must be considered.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 in the lap-band hero clinical study had an adverse event reported as gastroesophageal reflux.The patient was hospitalized, and had the lap-band removed and converted to a gastric sleeve following "chronic issues with gerd and esophageal spasm.".

• Brand Name: LAP-BAND AP LARGE WITH ACCESS PORT I
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5345552
• MDR Text Key: 35109542
• Report Number: 3006722112-2016-00003
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: 10811955020190
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

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: Physician
• Device Expiration Date: 04/14/2012
• Device Model Number: AP LARGE
• Device Catalogue Number: B-2245
• Device Lot Number: 1831785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2010
• 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: 31 YR
• Patient Weight: 162