MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP SMALL W/ RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND ACCESS PORT

Model Number B-20360

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weight Changes (2607)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

Rapidport ez strain relief.The reporter of the event was asked to return the product for analysis.Device labeling addresses the reported events 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.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.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.Patients must be carefully counseled on the need to report all vomiting, abdominal pain or other gastrointestinal or nutritional issues as these symptoms may indicate a condition not related to the lap-band® system.Special notice: the manufacturer of the lap-band ap® adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap® system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.

Event Description

Reported as: a patient with the lap-band system was reported to have "weight recovery, presence of brownish liquid during vacuuming.Pain at the site of the port, tinted liquid at the suction of the contents of the port." port was removed and replaced.

• Brand Name: LAP-BAND AP SMALL W/ RAPIDPORT EZ
• Type of Device: ADJUSTABLE GASTRIC BAND ACCESS PORT
• 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
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795100
• MDR Report Key: 7192026
• MDR Text Key: 97282908
• Report Number: 3006722112-2018-00014
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/22/2013
• Device Model Number: B-20360
• Device Catalogue Number: B-20360
• Device Lot Number: 2097254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 131