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

Model Number C-20360

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Strain relief.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the catalog number provided, the connector type is assumed to be a strain relief.If returned, visual examination may confirm or determine another taper type associated with this event.Further information has been requested of the initial reporter regarding: device serial number and patient information.To date, no additional information has been received by apollo.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.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 leak."after instilling 6 ml of saline in the port, [the physician] realized that in a short time there was only 2 ml remaining." the port was replaced.

Manufacturer Narrative

Strain relief.

Manufacturer Narrative

Strain relief.Supplement #2 - device evaluation summary: the device was returned to apollo, and a visual inspection was performed.The port tubing was separated approximately.5 inch from the port housing.Green particulate matter was observed on the inner surface of the strain relief.Green and brown particulate matter was observed on the port housing and anchors.The anchors were noted to be deployed.A port leak test was performed and leakage was observed.A fill inspection test was performed and no blockage was noted.Under microscopic analysis an unidentified opening was observed on the port tubing.Needle marks were observed on the port septum.The port tubing had a surgical end cut, consistent with device removal.

• Brand Name: LAP-BAND AP SMALL 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, costa rica ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7109621
• MDR Text Key: 95743911
• Report Number: 3006722112-2017-00413
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

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: Physician
• Device Expiration Date: 11/18/2018
• Device Model Number: C-20360
• Device Catalogue Number: C-20360
• Device Lot Number: AF00368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/12/2017; 02/27/2018
• Supplement Dates FDA Received: 12/13/2017; 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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: 14 YR
• Patient Weight: 120