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

Model Number B-2240

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

Patient Problems Dysphagia/ Odynophagia (1815); Regurgitation (2259)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

Taper unknown.Device labeling addresses the reported event as follows: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.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.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.Table 2: all adverse events that occurred at a rate of 5% or more for the us pivotal study in severely obese adults - seventy-five subjects had their entire lap-band® systems explanted.Fifty-one of the 75 explants (68%, 51/75) were counter measures to adverse events.Band slippage/ pouch dilatation and/or stoma obstruction was the most common adverse event associated with these explants (32%, 24/75).Other events associated with these explants were erosion (5%, 4/75), infection (4%, 3/75), gi disorders such as gastroesophageal reflux and/or dysphagia (11%, 8/75), lapband® system leak (4%, 3/75); one needle damage to shell and 2 access-port tubing leaks; esophageal disorders, such as dilatation and delayed emptying (7%, 5/75); gastric perforation (3%, 2/75); one abdominal pain; and 1 respiratory disorder.Insufficient weight loss was also reported as a contributor to the decision to explant in 24 of the 75 explants (32%, 24/75).Data from a post-approval study showed an estimated explant rate of 6.5% per year over the first 5 years following implantation.Warnings: patients should be advised that the lap-band ap® 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 experienced dysphagia and reflux.Device was removed.

Manufacturer Narrative

Taper ii.Supplement #1: medwatch sent to fda on 01/09/2019.Additional information: device evaluation summary: a visual examination was performed on the returned lap-band with access port i, taper type ii.The band tubing was noted to be separated approximately 2.5 inches from the port tubing ss connector.Needle marks were observed on the port septum.The band buckle strap was noted to be partially separated in two places.White and brown particles were observed on the inner surface of the band shell.An air leak test was performed, and no leakage was noted.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum and tubing.Under microscopic analysis, both ends of the band tubing were observed to have striated edges, consistent with a surgical end cut to remove the device.Needle marks were observed on the port septum.Brown particles were observed on the inner surface of the band shell.The band buckle strap was noted to be partially separated in two places.Both partial separations were approximately 0.1 inches in length, and both were observed to have a striated origination point, consistent with damage from a surgical tool.

• Brand Name: LAP-BAND AP STANDARD W/ 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
• MDR Report Key: 8175049
• MDR Text Key: 130684555
• Report Number: 3006722112-2018-00322
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2012
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 1805316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 84