MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP LARGE SYSTEM WITH RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number C-20365

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Strain relief.Device evaluation summary: the device was returned to apollo for analysis and noted only the rapidport ez was received.The strain relief was noted to be missing.Needle marks were noted on the port septum and scratches were noted on the port housing.Red particles were observed on the port base and port holes.The port tubing was noted to be separated approximately 1.5 inches past the port stainless steel connector.A port leak test was performed and leakage was noted from one opening on the port tubing near the port stainless steel connector.An air leak test was not feasible, as only the rapidport ez was received.A fill inspection test was performed and no blockage was observed.Under microscopic analysis, the opening on the port tubing was noted to be unidentified.It was also observed, that the end of the port tubing, was noted to have striated edges consistent with damage from a surgical end cut to remove the device.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.When adjusting band volume, take care to ensure the radiographic screen is perpendicular to the needle shaft (the needle will appear as a dot on the screen).This will facilitate adjustment of needle position as needed while moving through the tissue to the port.Failure to enter the port with the needle perpendicular to the port may cause damage to the access 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.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 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 loss of restriction.Leak diagnosed via 3 x volume deficits." the device was removed.

• Brand Name: LAP-BAND AP LARGE SYSTEM WITH RAPIDPORT EZ
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 7974520
• MDR Text Key: 124527534
• Report Number: 3006722112-2018-00261
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2018

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
• Device Operator: No Information
• Device Expiration Date: 10/04/2019
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Device Lot Number: AF01303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2017
• 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: 41 YR
• Patient Weight: 130