MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP-BAND AP SMALL W/ ACCESS PORT II; ADJUSTABLE GASTRIC BAND

Model Number B-20260

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Taper ii.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connector type is assumed to be a taper ii.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event as follows: caution: failure to use an appropriate atraumatic instrument such as the lap-band® system closure tool to lock the band may result in damage to the band or injury to surrounding tissues.Adverse events: ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Warnings: failure to secure the band properly may result in its subsequent displacement and necessitate reoperation.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 "repositioning of the lapband port.Opening of the ring.Weight gain." the nurse clarified noting "it is the loop that has disengaged but closing the loop that was pulling too much on the port tubing and the port itself so it had to change and reposition the port also." the port was removed and replaced.

• Brand Name: LAP-BAND AP SMALL W/ ACCESS PORT II
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital tx hwy; bldg. 1 suite 300; austin TX 78746
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital tx hwy; bldg. 1 suite 300; austin, TX 78746
• MDR Report Key: 7014379
• MDR Text Key: 92483415
• Report Number: 3006722112-2017-00375
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/13/2013
• Device Model Number: B-20260
• Device Catalogue Number: B-20260
• Device Lot Number: 2185145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2011
• 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 Weight: 89