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

Model Number	B-2220
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Taper ii.Medwatch sent to the fda on 06/13/2016.The reporter of the event was asked to inform apollo when explant surgery has been scheduled and to return the product for analysis.To date, apollo has not received an explant date or the device.Based on the serial number provided, the connecter type is assumed to be a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event of possible port/band leak as follows: precautions: care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.Adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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.
Event or Problem Description
Reported as: a patient with the lap-band system was reported to have a leak.The patient's lap-band system remains implanted.
Event or Problem Description
Updated information: device was removed and replaced.

• Brand Name: LAP-BAND 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: 5720741
• Report Number: 3006722112-2016-00158
• Device Sequence Number: 299175
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/09/2009
• Device Model Number: B-2220
• Device Catalogue Number: B-2220
• Device Lot Number: 1419079
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2016
• Supplement Report FDA Received Date: 12/07/2016
• 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: 89