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 Chest Pain (1776); Vomiting (2144)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may confirm or determine another taper type associated with this event.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.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.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 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 "complained of chest pain and vomiting, wanted band out." esophagogastroduodenoscopy (egd) was performed and no definite abnormalities.Device was removed.

Manufacturer Narrative

Taper ii.Medwatch sent to fda on 06/06/2018.Additional information: device summary evaluation: a visual examination was performed on the returned lap-band with access port i, taper type ii, and an additional piece of band tubing.Yellow particles were noted on the band belt near the belt/collar junction.The band ring and shell were noted to be separated near the band buckle.A partial separation was noted on the band buckle.Needle marks were noted on the port septum.Yellow particles were noted on the port near the port holes.Scratches were noted on the port housing and on the port holes.Yellow particles were noted on the port base.An air leak test was performed, and leakage was noted from an opening on the 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.The additional piece of band tubing was also tested, and no blockage was noted.Under microscopic analysis, both ends of the separated band ring and shell were noted to have striated edges, consistent with damage from a surgical end cut to remove the device.The end of the band tubing, separated approximately 0.25 inches past the collar, was noted to have an unidentified opening.One end of the additional piece of band tubing, approximately 2.2 inches in length, was noted to have an unidentified opening.The opposite end of the additional piece of band tubing, approximately 2.2 inches in length, was noted to have striated edges consistent with damage from a surgical end cut to remove the device.The end of the band tubing, separated approximately 10.4 inches past the ss connector, was noted to have striated edges, consistent with damage from a surgical end cut to remove the device.Needle marks were noted on the port septum.Non-penetrating nicks/marks were noted on the port housing, port base, and port holes.Both ends of the partial separation on the band buckle, approximately 0.45 inches in length, were noted to have striated edges, consistent with damage from a surgical end cut to remove the device.

• Brand Name: LAP-BAND SYSTEM
• 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: 7487225
• MDR Text Key: 107376625
• Report Number: 3006722112-2018-00121
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 147