MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP-BAND EZ ACCESS PORT KIT 10CC; ADJUSTABLE GASTRIC BAND

Model Number C-20304

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Seroma (2069)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to indicate product serial number.To date, apollo has not received the device information.It was indicated that the device would not be returned.Device labeling addresses the reported events as follows: 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.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.In addition, the lap-band ap® system may be easily damaged by improper handling or use.

Event Description

Reported as: a patient with the lap-band system was reported to have pain and seroma."one of the anchors had not deployed and hence was rubbing against a nerve." the port was removed and replaced.

Manufacturer Narrative

Strain relief.Supplement #1- medwatch sent to the fda on 26-jul-2017.

• Brand Name: LAP-BAND EZ ACCESS PORT KIT 10CC
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 300; austin TX 78746
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746
• MDR Report Key: 6679257
• MDR Text Key: 78776291
• Report Number: 3006722112-2017-00253
• 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
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: C-20304
• Device Catalogue Number: C-20304
• Device Lot Number: AF00308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 63