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

Model Number	B-2245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to fda on 05/03/2018.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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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 had their lap-band system removed due to "pain at port side and dysphagia".
Additional Manufacturer Narrative
Taper ii.Medwatch sent to fda on 06/04/2018.Additional information: device summary evaluation: a visual examination was performed on the returned lap-band with access port i and taper type ii.Needle marks were noted on the port septum.Yellow particles were noted on the port housing.White particles were noted to be covering approximately 20% of the outer surface of the band shell.The band was noted to be separated near the shell belt junction.Two partial separation were noted on the band buckle.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 not feasible, as the band was separated near the belt.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.Both ends of both partial separations on the band buckle, approximately 0.3 and 0.18 inches in length, were noted to have striated edges, consistent with damage from a surgical tool.Material degradation was noted to be covering approximately 20% of the outer surface of the band shell.Red particles were noted on the outer surface of the band shell.The end of the band tubing, separated approximately 16.1 inches past the collar, 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.A non-penetrating nick/mark, approximately 0.45 inches in length, was noted on the port housing.The end of the band tubing, separated approximately 1.45 inches past the ss connector, was noted to have striated edges, consistent with damage from a surgical end cut to remove the device.

• Brand Name: LAP-BAND AP LARGE 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: 7484615
• Report Number: 3006722112-2018-00118
• Device Sequence Number: 19230607
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: 10811955020190
• 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: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 03/04/2010
• Device Model Number: B-2245
• Device Catalogue Number: B-2245
• Device Lot Number: 1566826
• 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 Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: 47 YR
• Patient Weight: 104