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

Model Number B-2101

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Inflammation (1932)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

Unknown taper.\ this report captures the patient's second port removal.The original port and band that was removed with this system will be captured under mdr 3006722112 2017 00353.Device labeling addresses the reported event as follows: precautions: the band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract.Any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution.The use of such medications may be associated with an increased risk of erosion.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 there is a risk of band erosion into stomach tissue.Erosion of the band into stomach tissue has been associated with revision surgery, after the use of gastric irritating medications, after stomach damage and after extensive dissection or use of electrocautery, and during early experience.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Re-operation to remove the device is required.Warning: the manufacturer of the lap-band® adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band® 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, and component.

Event Description

Reported as: the patient's lap-band system was reported to have complication."patient was in a rehab hospital for complications from panniculitis and [the] physician requested an egd be done and the band was found to be eroded into the stomach." port was removed.

• Brand Name: LAP-BAND ACCESS PORT KIT
• 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): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial tx hwy; bldg. 1 suite 300; austin, TX 78746
• MDR Report Key: 6974750
• MDR Text Key: 90147855
• Report Number: 3006722112-2017-00384
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 01081195520084
• UDI-Public: 1081195520084
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/20/2013
• Device Model Number: B-2101
• Device Catalogue Number: B-2101
• Device Lot Number: 2149545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2011
• 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: 58 YR