MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND SYSTEM 10.0CM; ADJUSTABLE GASTRIC BAND

Model Number 10.0CM

Device Problem Leak/Splash (1354)

Patient Problem Choking (2464)

Event Date 01/01/2011

Event Type  malfunction  

Manufacturer Narrative

Taper ii.Medwatch sent to fda on: 10/21/2015.The product is not available for analysis as it remains implanted.Based on the device serial number provided it is assumed the connecter type associated with this complaint is a taper ii.If explanted and returned, visual examination may confirm or determine another taper type associated with this complaint.This event was reported by the patient.Apollo has requested additional information regarding the patient's report of "choking." to date, no additional information has been received.Apollo has been unable to confirm the events with the patient's treating physician.To date, no intervention/treatment has been scheduled or performed.Device labeling address the possibility of a leak as follows: adverse events: unplanned 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 system is a long-term implant.Explant (removal) 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.Device remains implanted.

Event Description

Reported as: the patient reported that about one year after having the lap-band system implanted, they started "choking" on their food.Patient also stated that around this time the band was only maintaining restriction "for maybe 30 days." diagnostic testing was performed, and showed the lap-band "was not holding the fluid." the lap-band system remains implanted.No intervention or treatment has been performed to date.

Manufacturer Narrative

Device labeling addresses the additional report of dysphagia as follows: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.

Event Description

Originally reported as: the patient reported that about one year after having the lap-band system implanted, they started "choking" on their food.Patient also stated that around this time the band was only maintaining restriction "for maybe 30 days." diagnostic testing was performed, and showed the lap-band "was not holding the fluid." the lap-band system remains implanted.No intervention or treatment has been performed to date.Follow-up with the patient clarified that the "choking" episodes were the patient adjusting to the band.The patient reported the food would feel stuck and would take some time to go down, resulting in difficulty swallowing and obstruction.No intervention was required nor hospitalization.

• Brand Name: LAP-BAND SYSTEM 10.0CM
• Type of Device: ADJUSTABLE GASTRIC BAND
• 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, costa rica ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s capitol of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5167192
• MDR Text Key: 28911937
• Report Number: 3006722112-2015-00486
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

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: 12/18/2010
• Device Model Number: 10.0CM
• Device Catalogue Number: B-20220
• Device Lot Number: 1693416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2009
• 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: 49 YR
• Patient Weight: 122