MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number AP STANDARD

Device Problem Leak/Splash (1354)

Patient Problems Adhesion(s) (1695); Pain (1994); Weight Changes (2607)

Event Date 04/28/2014

Event Type  Injury  

Manufacturer Narrative

Taper ii.The device was returned for analysis, and visual inspection confirmed the product associated with this complaint is a taper ii.Evaluation summary: the device was returned, and visual inspection noted the band tubing was separated/broken.A linear opening was also observed on the band tubing.A fill inspection found no blockage or resistance to flow.A leak test was performed on the band tubing, and a curved opening was noted.Microscopic analysis of the device observed sharp, unidentified openings on the lap-band and the band tubing.Device labeling address the possibility of a leak, adhesions, and device removal as follows: adverse events: unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Gastric banding done as a revision procedure has a greater risk of complications.Prior abdominal surgery is commonly associated with adhesions involving the stomach.In the us pivotal study of severely obese adults, 42% of the subjects undergoing revision surgery were reported to have adhesions involving the stomach.Care and time must be taken to adequately release the adhesions to provide access, exposure and mobilization of the stomach for a revision procedure.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 had the entire lap-band system removed and replaced due to a leak.The physician reported the patient "developed sudden onset of increased appetite, decreased satiety, increased weight, and abdominal pain, which brought [the patient] to the hospital." additional information from the operative report noted "completely transected tubing in the mid section of the of the intra abdominal portion secondary to tension caused by adhesions", "thick adhesions of the gastric pouch to the undersurface of the left lob of the liver.".

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT I
• 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: 5166940
• MDR Text Key: 28902578
• Report Number: 3006722112-2015-00457
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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
• 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: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/24/2013
• Device Model Number: AP STANDARD
• Device Catalogue Number: B 2240
• Device Lot Number: 2127360
• 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
• Date Device Manufactured: 05/24/2011
• 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: 43 YR
• Patient Weight: 105