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

Model Number VG

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Inflammation (1932); Abdominal Distention (2601); No Code Available (3191)

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.Medwatch sent to fda on 1/05/2016.The reporter of the event was asked to return the product for analysis, and to indicate product serial and/or catalog number.The reporter indicated the device would not be returned, and to date apollo has not received additional device information.Without the device or serial/catalog number, the connecter type associated with this event cannot be determined.The reporter of the event was asked for additional information regarding the event, including: the reason for removal, patient outcomes, patient age/weight/gender/relevant history, relevant laboratory tests, and device information.To date, no additional information has been received by apollo.Device labeling addresses the reported event of band removal as follows: 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.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.Gastric banding done as a revision procedure has a greater risk of complications.

Event Description

Reported as: the patient had the lap-band system removed without replacement.The physician attempted band replacement, however during the removal procedure felt it "was not safe to put a new band in.".

Manufacturer Narrative

Supplement #1 - medwatch sent to fda on 02/09/2016.Follow-up found the additional report of band slippage, inflammation, and distension.Device labeling addresses the reported events as follows: warning: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Adverse events: band slippage and/or pouch dilatation can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be successfully resolved by band deflation in some cases.More serious slippages may require surgery to reposition and/or remove the band.Immediate re-operation to remove the band is indicated if there is total stoma-outlet obstruction that does not respond to band deflation or if there is abdominal pain.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.Contraindications: the lap-band system is contraindicated in: patients with inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as crohn's disease.Adverse events: esophageal distension or dilatation has been infrequently reported.This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction.It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility.Deflation of the band is recommended if esophageal dilatation develops.A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.

Event Description

Follow-up with the physician reported that the reason for the lap-band system removal was band slippage.The reason for no replacement of the device was the physician felt it was "unsafe due to inflammation and distention.".

• Brand Name: LAP-BAND SYSTEM VG
• 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: 5345452
• MDR Text Key: 35158389
• Report Number: 3006722112-2016-00007
• Device Sequence Number: 1
• Product Code: LTI
• 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,Followup
• Report Date: 12/07/2015

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: Physician
• Device Model Number: VG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• 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
• Patient Age: 57 YR
• Patient Weight: 73