MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAGB SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number	B-2220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Regurgitation (2259); Patient Problem/Medical Problem (2688)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to fda on 03/01/2017.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: 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.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 "persistent gastroesophageal reflux disease, intolerance to adjustments.".
Additional Manufacturer Narrative
Taper ii.Device evaluation summary: a visual examination was performed on the received lap-band system with access port i, taper ii.The band tubing was separated near the belt.The buckle was separated from the band.Needle marks were noted on the port and port septum.The septum was noted to be discolored, and was brown in appearance.White particles were noted on the inner and outer surfaces of the 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.Under microscopic analysis, the end of the band ring and the buckle were noted to have a surgical end cuts, consistent with removal of the device.Also under microscopic analysis, the ends of the band tubing were noted to have a surgical end cut, consistent with damage from device removal.No unusual characteristics were noted on the access port and band shell/ring.

• Brand Name: LAGB SYSTEM 10CM
• 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: 6368616
• Report Number: 3006722112-2017-00068
• Device Sequence Number: 13765993
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: (01)10811955020169(11)051117(17)071116(10)1167048
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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: 11/16/2007
• Device Model Number: B-2220
• Device Catalogue Number: B-2220
• Device Lot Number: 1167048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 08/01/2017
• 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: 44 YR
• Patient Weight: 103