MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND 9.75 WITH ACCESS PORT II; ADJUSTABLE GASTRIC BAND

Model Number 9.75CM

Device Problem Leak/Splash (1354)

Patient Problem Weight Changes (2607)

Event Date 04/18/2014

Event Type  malfunction  

Manufacturer Narrative

Taper ii.The product was returned for analysis, and visual examination confirmed this was a taper ii.Evaluation summary: the access port was returned, and visual inspection observed a linear opening on the port tubing.A fill inspection of the access port revealed no blockage or resistance to flow.A leak test showed a linear opening at the tubing/port ss.A microscopic analysis of the device found a smooth-edged opening on the tubing/port ss.A striated opening, consistent with a surgical end-cut was noted on the band tubing.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.

Event Description

Reported as: the patient was experiencing an increase in appetite, decreased satiety, and increasing weight gain.The physician checked the lap-band and found 1cc of fluid, much less fluid than expected.The physician added 3cc and aspirated bubbles; no fluid was returned.The physician confirmed a port leak.The port was removed and replaced.Follow-up found that the operative report indicated a "hole in the tubing portion of the port" and a "previous transverse scar was noted in the upper abdomen with the port palpable underneath.".

• Brand Name: LAP-BAND 9.75 WITH ACCESS PORT II
• 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: 5167592
• MDR Text Key: 28910469
• Report Number: 3006722112-2015-00458
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020152
• UDI-Public: 10811955020152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 9.75CM
• Device Catalogue Number: B-2215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 67 YR
• Patient Weight: 67