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

Model Number B-2245

Device Problem Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144)

Event Date 03/30/2014

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 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.Care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity or subsequent surgery.Failure to do so may result in the inability to perform percutaneous band adjustments.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.Patients must be carefully counseled on the need for proper dietary habits.They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection.The physician may choose to prescribe appropriate dietary supplements.Appropriate physical monitoring and dietary counseling should take place regularly.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.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: a large hiatal hernia may prevent accurate positioning of the device.Placement of the band should be considered on a case-by-case basis depending on the severity of the hernia.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: the patient underwent bariatric surgery five years ago.At the time of [patient's] surgery an incarcerated umbilical hernia was repaired, and the laparoscopic adjustable port was placed at the umbilicus overlying this repair.The patient has had some tenderness at this port site.[patient] failed to really lose any significant weight with [the] lap band.[patient] has not followed a bariatric diet.Recently [patient] has had difficulty with both solid and liquid foods with worsening dysphagia.Per physician, "having a lot of trouble keeping food and liquids down, [patient] is vomiting all the time and is having pain where the lap band port is.Unfortunately, the port seems to have rotated in its position relative to the skin in the periumbilical abdominal wall.I am unable to access the port with a huber needle despite multiple attempts." the patient underwent lap band removal.Per operative report: 'a left periumbilical incision was made.The visiport was used to traverse the abdominal wall entering the peritoneal cavity under direct vision.Pneumoperitoneum was achieved without difficulty.The band tubing adjacent to the band itself was grasped and retracted.This allows dissection along the band tubing up to the band buckle.The buckle was dissected free and unbuckled.The band was cut adjacent to the buckle and removed from its position around the gastric cardia.Two pieces of the band were then removed through the 15-mm trocar site.Hemostasis was confirmed.Liver retractor was removed.Trocar sites were each removed and hemostasis at the trocar sites was confirmed.Pneumoperitoneum was reversed.A skin incision was made over the periumbilical port site.The port was dissected free and removed with all the adjacent tubing present.The band was reconstructed on the back table, confirming all 3 components were accounted for.The wounds were closed in 2 layers.Sterile dressings were applied.The patient tolerated the procedure well, was extubated and transported to the post-anesthesia recovery room in stable condition.'.

Manufacturer Narrative

Taper ii.Supplement #1: medwatch sent to fda on 01/28/2019.Additional information: corrected data: 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 near the collar.Yellow and white particulate matter was noted on the port septum, port housing, port holes, and port base.Scratches were observed on the port housing, port base, and on one port hole.The band was noted to be separated near the shell/belt junction.The band buckle strap was noted to be partially separated.An air leak test was performed, and the band was noted to be leaking from the ring and shell where the band was separated near the shell/belt junction.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 separated band ring and shell were noted to have striated edges, consistent with damage from a surgical tool.The band tubing was separated approximately 0.95 inches from the collar.Both ends of the separated band tubing were observed to have striated edges, consistent with a surgical end cut to remove the device.Needle marks were noted on the port septum.Multiple non-penetrating nicks/marks were observed on the port housing, port base, and on one port hole.The band buckle strap was noted to be partially separated.Both ends of the partially separated section of buckle strap were observed to have striated edges, consistent with damage from a surgical tool.

Event Description

Follow up findings per reporter: patient went to the emergency room (er) for peri-umbilical pain.Diagnostic tests confirmed "there is a band encircling the upper stomach near the gastroesophageal junction without a significant gastric pouch demonstrated.".

• Brand Name: LAP-BAND AP LARGE 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: 8200541
• MDR Text Key: 131535561
• Report Number: 3006722112-2018-00331
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2015
• Device Model Number: B-2245
• Device Catalogue Number: B-2245
• Device Lot Number: 2506192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOSARTAN POTASSIUM HTZ; MULTIVITAMIN; NEXIUM; VITAMIN D3; ZYRTEC
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 150