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	Failure of Implant (1924)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
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.Without the device, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Device labeling addresses the reported event 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: 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.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warning: patients should be advised that the lap-band 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: a patient with the lap-band system was reported to have a leak."[patient] went from 252 to 151 in the first 2 years after placement, then gradually regained about 40 pounds, having last seen [physician] in 2015 for a "fill" that [patient] reported had no effect.The [physician] tried adjusting the band with no success a month or more ago.This led them to suspect a leaking port.A ct was performed and they were able to 'see' the intra-abdominal tubing.The ct scan "shows two distinct ends of tubing free in the pelvis".Device has been removed.
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.The band tubing was separated approximately 6.25 inches from the collar.The port tubing was separated approximately 9.25 inches past the stainless steel connector.Needle marks were observed on the port septum.Scratches and brown particulate matter were noted on the port housing; in addition an opening was observed on the port housing.Brown particles were also observed in the port holes, and on the port taper and tubing.Brown and red particles were noted on the band belt, collar, buckle, buckle strap, ring, and shell.The buckle strap was noted to be partially separated.A port leak test was performed and no leakage was noted.A fill inspection test was performed and blockage was observed, fluid was unable to be injected in the port septum.An air leak test was performed and leakage was noted from the band tubing, approximately 0.35 inches from the end of the tubing.During testing, the band tubing separated at the point from which it was leaking.Under microscopic and visual inspection, two cracks were noted on the port housing at the opening on the port.The opening on the port housing was observed to have sharp edges.The portion of the band tubing which separated during testing was inspected; under microscopic analysis the end of the tubing was noted to have striated edges, consistent with a surgical end cut to remove the device.The opposite end of the piece of separated band tubing, where the leakage was noted to be coming from during the air leak test, was noted to have a sharp opening with jagged edges, consistent with brittle tubing.White discoloration was observed at the band tubing edges, consistent with brittle tubing appearance.The end of the port tubing and both ends of the buckle strap were noted to have striated edges, consistent with damage from surgical end cuts to remove the device.

• Brand Name: LAP-BAND SYSTEM 10CM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin TX 78746
• MDR Report Key: 7229682
• Report Number: 3006722112-2018-00020
• Device Sequence Number: 869136
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: 04/22/2008
• Device Model Number: B-2220
• Device Catalogue Number: B-2220
• Device Lot Number: 1250412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 94