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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Taper ii: this event was reported by the patient.Apollo has been able to confirm the reported events with the patient's physician.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connecter type as taper ii.Yellow discoloration was observed on the outer surface of the port tubing.Brown particles were observed on the outer surface of the port base.A port leak test was performed and leakage was observed.A fill inspection test was performed and no blockage or resistance to flow was noted.Under microscopic analysis, one smooth-edged opening was observed on the taper tubing junction, related to wear and abrasion.Three striated openings were observed on the port tubing.Analysis noted approximately ten scratches on the outer surface of the port housing and base.Device labeling addresses the reported event of 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: 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.Deflation of the band may occur due to leakage from the band, the port or the connecting tubing.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 Description

Reported as: a patient with the lap-band system was reported to have a "cracked tubing by the port" which was confirmed by an x-ray.It was observed when the patient went to get a fill and it "felt loose." the device has been removed.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 6124864
• MDR Text Key: 60876138
• Report Number: 3006722112-2016-00342
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/24/2016

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
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 109