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); Patient Problem/Medical Problem (2688)
Date of Event	05/11/2017
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 confirm the 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.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 entire lap-band system removed due to "intolerance to adjustments and dysphagia with base".
Additional Manufacturer Narrative
Taper ii.Supplement #1: medwatch sent to fda on 03/12/2018.Device evaluation summary: a visual examination was performed on the received lap-band with access port i, taper type ii.The band tubing was noted to be separated approximately 1.5 inches from the tubing/collar junction.Needle marks were observed on the port septum and port housing.The belt was noted to be separated from the band at 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.An air leak test was performed, and leakage was noted from one opening on the band shell at the end plug.One opening was observed on the band shell at the end plug.The edges of the opening were striated, consistent with damage from a surgical tool.Under microscopic inspection, the end of the belt at the shell/belt junction had striated edges consistent with a surgical end cut to remove the device.Needle marks were noted on the port septum, and scratches were noted around the port septum on the port housing.The end of the port tubing had striations, consistent with a surgical end cut.The band tubing was also noted to have a surgical end cut, as the end of the tubing had striated edges.

• 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: 7003924
• Report Number: 3006722112-2017-00361
• Device Sequence Number: 156254
• 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): 03/07/2018

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: 03/31/2011
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 1716372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 03/12/2018
• 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: 42 YR
• Patient Weight: 124