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

Device Problem Malposition of Device (2616)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fever (1858); Unspecified Infection (1930); Pain (1994); Obstruction/Occlusion (2422); Weight Changes (2607)

Event Date 06/14/2013

Event Type  Injury  

Manufacturer Narrative

Unknown taper.The device is not available for analysis.The patient was asked for additional information regarding their explant surgeon so device return could be requested, to date apollo has not received contact information.Additional device information regarding serial and catalog number has been requested of the patient and their implanting physician, no further information has been received to date.This event has been reported by the patient.Further information regarding the patient's explanting physician and event details has been requested of the patient.No new information has been received to date.Device labeling addresses the reported event as follows: precautions: revision procedures may require the existing staple line to be partially disrupted to avoid having a second point of obstruction below the band.As with any revision procedure, the possibility of complications such as erosion and infection is increased.Any damage to the stomach during the procedure may result in peritonitis and death or in late erosion of the device into the gi tract.Anti-inflammatory agents, such as aspirin and nonsteroidal anti-inflammatory drugs (nsaids), may irritate the stomach and should be used with caution.The use of such medications may be associated with an increased risk of erosion.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.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.Reoperation to remove the device is required.Warning: any damage to the stomach during the procedure may result in erosion of the device into the gi tract.Caution: do not over-dissect the opening.Excessive dissection may result in movement or erosion of the band.Adverse events: infection can occur in the immediate post-operative period or years after insertion of the device.In the presence of infection or contamination, removal of the device is indicated.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 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 mw5044410 as: the patient reported they had the lap-band system placed, and following placement they experienced weight loss.The patient had band adjustments performed, and reported no other issues with the lap-band other than "rare instance that a piece of food got stuck and that didn't last very long." four years after placement they were diagnosed with a diseased gall bladder and had their gall bladder removed.Three days after surgery the patient began running a fever that lasted over the next three weeks.The patient returned to the surgeon's office and the emergency room, was given iv fluids and a short course of cipro and told to force themselves to eat.Patient reported their white blood cell count was down twice prior to surgery and was on the low side of normal.It started climbing and was way out of normal range before a cat scan was done that showed they had developed a "massive abdominal infection." patient spent the next seven weeks in hospital, had antibiotics administered, and underwent surgery to remove the band and flush the abdominal cavity.Following surgery the patient used a wound-vac for five weeks.Patient reported their band had eroded into their stomach and they had had sepsis.The patient is left with a damaged stomach and a scar that is sensitive.The patient reported they were told their band was not in the proper position.The patient had to take antibiotics so strong their hair fell out and changed texture when it grew back in.Follow-up with the patient confirmed the original report.The patient clarified they had an ultrasound and mri for their gallbladder issue, and were left with an eight inch scar.The patient also reported that since having the band removed they have had to have surgery for a small bowel obstruction and were told it was caused by adhesions from their lap-band.

• Brand Name: LAP-BAND SYSTEM
• 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: 5221624
• MDR Text Key: 31077246
• Report Number: 3006722112-2015-00526
• 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,other
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2015
• 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: TYLENOL (AS NEEDED)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 90