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

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Without the device or device serial number, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Further information has been requested of the initial reporter regarding: implant date, explant date, date of occurrence, and patient information.To date, no additional information has been received by apollo.Device labeling addresses the following complaint as follows: precautions: 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.Symptoms of band erosion may include reduced weight loss, weight gain, access port infection, or abdominal pain.Reoperation to remove the device is required.Re-operation for band erosions may result in a gastrectomy of the affected area.Eroded bands have been removed gastroscopically in a very few cases.Consultation with other experienced lapband® system surgeons is strongly advised in these cases.Warnings: 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.The band should not be sutured to the stomach.Suturing the band directly to the stomach may result in erosion.

Event Description

Literature review performed: revisional surgery after removal of eroded adjustable gastric bands.Cho e, kim, sm asian journal of surgery.Https://doi.Org/10.1016/j.Asjsur.2018.11.003.This article noted 39 patients who experienced band removal due to band erosion.This report is to capture the twenty-sixth of twenty-eight unknown band erosions.Follow-up with the author of the article has been conducted and we have been unable to confirm the manufacturer of the device.Although the manufacturer of the device is unknown, it is apollo's approach to compliance to resolve all doubt in favor of reporting.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8320762
• MDR Text Key: 135534633
• Report Number: 3006722112-2019-00050
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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