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

Model Number	B-2240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Vomiting (2144)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional 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 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.Patients must be cautioned to chew their food thoroughly.Patients with dentures must be cautioned to be particularly careful to cut their food into small pieces.Failure to follow these precautions may result in vomiting, stomal irritation and edema, possibly even obstruction.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: 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 or Problem Description
Reported as: the patient's lap-band system was explanted due to "dysphagia and vomiting".
Additional Manufacturer Narrative
Device evaluation summary: a visual examination was performed on the returned lap-band with access port i, taper type ii, with an additional piece of tubing.The port tubing was noted to be separated approximately 1 inch past the ss connector.Needle marks were observed on the port septum, and scratches were noted on the port housing.The band tubing was noted to be separated at the tubing-collar junction.White 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.The additional piece of tubing was also tested, and no blockage was noted.Under microscopic analysis, material degradation was noted on approximately 10% of the outer surface of the band shell.A non-penetrating nick/mark was noted on the outer surface of the band ring, approximately 1.2 inches from the buckle, and was noted to have striated edges, consistent with damage from a surgical tool.The buckle strap was noted to have an unidentified partial separation, approximately 0.1 inches in length.A non-penetrating nick/mark was noted on the port hole.Needle marks were noted on the port septum.Non-penetrating nicks/marks were noted on the port near the port septum.The end of the port tubing was noted to have striated edges, consistent with damage from a surgical end cut to remove the device.Both ends of the additional piece of tubing were noted to have striated edges, consistent with damage from a surgical end cut to remove the device.Blue, black, and yellow particles were noted on the ends of the additional piece of tubing.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT I
• Common Device Name: 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: 7244540
• Report Number: 3006722112-2018-00027
• Device Sequence Number: 19089963
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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
• Operator of Device: Physician
• Device Expiration Date: 04/02/2011
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 1717260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 88