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

Device Problems Material Erosion (1214); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Erosion (1750); Nausea (1970); Regurgitation (2259); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

Taper unknown.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without device or device serial, the taper type is unknown.If returned, visual examination may determine the connecter 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.As with gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.It is the responsibility of the surgeon to advise the patient of the dietary restrictions that follow this procedure and to provide diet and behavior modification support.Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight.Insufficient weight loss may be caused by pouch enlarge-ment or, more infrequently, band erosion in which case further inflation of the band would not be appropriate.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.Band slippage and/or pouch dilatation can occur.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.There is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery after the use of gastric-irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection or abdominal pain.Reoperation to remove the device is required.Reoperation for band erosions may result in a gastrectomy of the affected area.Eroded bands have been removed gastroscopically in a very few cases.Consultation with other experienced lap-band® system surgeons is strongly advised in these cases.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: failure to secure the band properly may result in its subsequent displacement and necessitate a second operation.The band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.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: healthcare professional reported for a lap-band system patient "lap gastric banding device placed many years prior.Adjustment done several years ago.Per history, a year ago there has been some evidence of band slippage on upper gastrointestinal (ugi).A few months ago, the patient underwent laparoscopic removal of eroded adjustable gastric band with omental patch repair of gastric erosion.Excerpts from operative report: careful dissection revealed that the lap band had eroded into the stomach with the tubing emerging through the gastric wall.The band was mobilized to expose the buckle.The band was unbuckled and the band was found to be entirely inside the gastric lumen with posterior mucosal bridge.The band was removed from the stomach.The tubing was cut and the band was removed from the abdomen.Grossly, the band had chronic changes due to gastric acid exposure.The gastric erosion site was then repaired.Patient developed increased nausea and gerd symptoms with weight gain.Ugi revealed 76 degree angle of band with slip to distal fundus".

Manufacturer Narrative

Supplement #1: medwatch sent to fda on 09/22/2017.Device evaluation summary: a visual examination was performed on the received lap-band with access port ii, taper type ii.The port tubing was separated from the band tubing approximately 2 inches from the taper tubing junction.Needle marks were noted on the port septum, and yellow particulate matter was noted on one port hole.The lap-band was noted to be discolored, and the belt, ring, shell, buckle, and buckle strap were brown, black, and tan in appearance.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum and tubing.An air leak test was performed, and the band was leaking from the shell at the shell/belt junction.Under microscopic analysis, needle marks were observed on the port septum.The end of the port tubing was observed to be surgically cut, as the edges were noted to have striations.The end of the band tubing, where a portion of the ss connector was visible, was noted to have a striated surgical end cut.The band shell was noted to be separated from the belt at the shell/belt junction.The edges of the shell where it has separated from the belt were noted to be sharp.An opening was observed on the band shell approximately 1/10 of an inch from the belt.The edges of the opening were observed to be sharp.Under microscopic and visual analysis, the band shell and ring appeared to be degraded.White particles were noted to be covering approximately 75% of the outer surface of the shell.

• 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
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 6846075
• MDR Text Key: 85016395
• Report Number: 3006722112-2017-00313
• Device Sequence Number: 1
• Product Code: LTI
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 96