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

Model Number VG

Device Problem Device Slipped (1584)

Patient Problems Aspiration/Inhalation (1725); Nerve Damage (1979); Swelling (2091); Vomiting (2144)

Event Date 06/01/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper medwatch sent to fda on: 11/12/2015.The patient's physician was asked if the device was available for analysis, the reporter stated it was discarded.The patient's implanting and explanting physicians were asked for device information such as serial or catalog number, both stated it was unknown.Without device return and no serial or catalog information, the connecter type associated with this complaint cannot be determined.This event was originally reported by the patient, including reports of esophageal swelling and nerve damage leading to loss of full sensation.Further follow-up with the patient's s physician found no report of esophageal swelling or nerve damage.Device labeling addresses the possible outcome of band slip 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.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.Warning: 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 via mw5044399: the patient reported they had the lap-band system placed, and after a year and a half they had problems keeping food down, vomiting, acid reflux and night aspiration.The patient had several adjustments performed.The patient complained of no restriction, and had the lap-band taken out.The patient reported their physician told them the "lap-band slipped up off my stomach onto my esophagus causing massive swelling." follow-up with the patient found they had their lap-band system explanted and converted to a gastric sleeve.The patient confirmed their original report, and also reported they have no sensation of being full and their physician told them they have nerve damage.Follow-up with the patient's physician found the patient requested they be converted from the band to a gastric sleeve.Reporter noted the patient did not have diagnostic testing prior to surgery.Operative report from the surgery noted the band was in a slipped position, but there was no report or confirmation of the esophageal swelling originally reported by the patient.The physician's office stated the patient was not diagnosed with nerve damage, but that the patient had been informed that following conversion from band to sleeve, patients are sometimes desensitized to the effects of the procedure, and weight loss can be slower.

• 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: 5221625
• MDR Text Key: 31077097
• Report Number: 3006722112-2015-00525
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 10/14/2015

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
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/13/2015
• 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
• Treatment: PRILOSEC (RX)
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 108