MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM ACCESS PORT II KIT; ADJUSTABLE GASTRIC BAND

Model Number	B-2103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Regurgitation (2259)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Taper ii.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connector type is assumed to be a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.This report captures the port that was removed with the band.It appears that the physician used a port from a port kit with the original band placement.The band removal was captured under mdr 3006722112 2017 00011.Device labeling addresses the reported events of gerd and dysphagia 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.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 reported to have a "several years of gerd and dysphagia." the patient's port was explanted.
Additional Manufacturer Narrative
Taper ii.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.A visual examination was performed on the port, and noted brown discoloration on the port tubing.The taper tubing junction was noted to be at an angle.Scratches were observed on the access port and port holes.Needle marks were noted on the port septum.A fill inspection test was performed and no blockage was observed.Under microscopic analysis, two smooth-edged openings were observed on the port tubing, consistent with wear and thinning.One of the openings was noted to be at the port tubing junction.The band tubing attached to the ss connector had surgical end cuts, consistent with device removal.

• Brand Name: LAP-BAND SYSTEM ACCESS PORT II KIT
• 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: 6237351
• Report Number: 3006722112-2017-00030
• Device Sequence Number: 709867
• Product Code: LTI
• UDI-Device Identifier: 10811955020091
• UDI-Public: (01)10811955020091(11)080725(17)100724(10)1634284
• 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 Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 07/24/2010
• Device Model Number: B-2103
• Device Catalogue Number: B-2103
• Device Lot Number: 1634284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 06/15/2017
• 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: 56 YR
• Patient Weight: 98