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

Model Number B-2245

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The device labeling addresses the reported event as follow: precautions: care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.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 unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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 a "hole in it".The device was removed.Additional information noted that "a couple of months ago" patient experienced stomach pain, described like a rubber band breaking.The pain went away, however the patient did not feel full and continued to gain weight.A barium swallow and x-ray confirmed the device had a leak.

Manufacturer Narrative

Taper ii.Supplement #1 - medwatch sent to the fda on 11/feb/2019.Additional information: a review of the manufacturing records associated with this device found the subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.A visual examination was performed on the returned lap-band with access port i, taper type ii.The access port was received still attached to the band.To perform the port leak test, the access port was removed from the lap-band by disconnecting the port tubing from the band tubing at the ss connector.The ss connector was still present within the end of the band tubing.A port leak test was performed and no leakage was observed.An air leak test was performed and leakage was noted from the one opening on band shell.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, a smooth-edged opening was observed along the length of the end plug/shell junction, near the band buckle; this finding is consistent with a potential workmanship issue, due to lack of adhesive.The opening was approximately 0.2 inches in length.Several non-penetrating nicks/marks were noted on the band ss connector.Needle marks were noted on the port septum.Non-penetrating nicks/marks were noted on the port housing, the port holes, and the port base.

• Brand Name: LAP-BAND AP LARGE W/ ACCESS PORT I
• 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: 8066915
• MDR Text Key: 128254065
• Report Number: 3006722112-2018-00282
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: 10811955020190
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2016
• Device Model Number: B-2245
• Device Catalogue Number: B-2245
• Device Lot Number: 2673512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERIODS
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 76