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

Model Number	B-2101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Adhesion(s) (1695)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to fda 02/23/2017.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.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.When adjusting band volume, the needle must be inserted perpendicular to the access port septum.Failure to do so may cause damage to the port and result in leaks.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.Gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the us pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach.Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.
Event or Problem Description
Reported as: a patient's lap-band system was reported to have a "port revision due to tubing leak." per op report, "verified that the break was an excessive angulation of the tubing that was kinked, there was some scar tissue at the entrance of the tubing that was probably creating a kink around that tubing area." the port was removed and replaced.

• Brand Name: ACCESS PORT KIT
• Common Device Name: ADJUSTABLE GASTRIC BAND ACCESS PORT
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 6355269
• Report Number: 3006722112-2017-00053
• Device Sequence Number: 13847212
• Product Code: LTI
• UDI-Device Identifier: 10811955020084
• UDI-Public: (01)10811955020084(11)101005(17)121005(10)2028565
• Combination Product (Y/N): N
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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: Physician
• Device Expiration Date: 10/05/2012
• Device Model Number: B-2101
• Device Catalogue Number: B-2101
• Device Lot Number: 2028565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMBIEN; BUPROPION HCI XL; DICLOFENAC ER; ESCITALOPRAM; LEXAPRO; LOVASTATIN; LOVOTHYROXINE; VOLTAREN; WELLBUTRIN; ZOLPIDEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 68