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 08/11/2018

Event Type  malfunction  

Manufacturer Narrative

Rapidport ez strain relief.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as a rapidport ez strain relief.The band tubing was noted to be separated past the port tubing ss connector.Scratches and needle marks were noted on the outer surface of the port septum.The port tubing connection and strain relief appear to be securely affixed to the port.Green, yellow and blue particulate matter was observed on the port at the port tubing connection, as well as on the port hole and port base.The port hole located on the port base, opposite the port tubing connection was observed to be bent outwards, with no separation.Yellow particulate was were noted on the inner surface of the strain relief.A port leak test was performed and leakage was observed from the port hole on the port base when the port tubing was positioned at an angle.No leakage was observed during the port leak test when the port tubing was tested in a straight configuration from the port. an air leak test was not feasible as the band was not returned with the port.A fill inspection test was performed and no blockage was observed when di water was injected through the port septum, or through the port tubing.Under microscopic analysis, the end of the band tubing, separated approximately 1.4 inches past the port tubing ss connector 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: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.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 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." during theatre for port replacement a leak was clearly demonstrated at the shoulder / joint connector of the port.

• 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): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8180299
• MDR Text Key: 131806049
• Report Number: 3006722112-2018-00325
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2019
• Device Model Number: C-20365
• Device Catalogue Number: C-20365
• Device Lot Number: AF00545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• 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: 37 YR
• Patient Weight: 72