MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2240

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Dehydration (1807); Internal Organ Perforation (1987); Vomiting (2144)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Taper ii medwatch sent to fda on 06/20/2016.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.A visual inspection was performed on the device, and noted brown particles on the port, the port septum, the band belt and the band buckle.A port leak test was performed, and no leakage was noted.An air leak test was performed on the band, and no leakage was noted.A fill inspection test was noted, and no blockage or resistance to flow was noted.Microscopic analysis noted that the band tubing was broken with striations consistent with surgical end cut to remove the device.The events reported are surgical/physiological complications and analysis of the device generally does not assist apollo in determining a probable cause for this event.Device labeling addresses possible outcomes of dehydration, vomiting, stomach perforation and abscess as follows: warning: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.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.Ulceration, gastritis, gastroesophageal reflux, heartburn, gas bloat, dysphagia, dehydration, constipation, and weight regain have been reported after gastric restriction procedures.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.Nausea and vomiting may also be symptoms of stoma obstruction or a band/ stomach slippage.Frequent, severe vomiting can result in pouch dilatation, stomach slippage or esophageal dilatation.Deflation of the band is immediately indicated in all of these situations.Deflation of the band may alleviate excessively rapid weight loss and nausea and vomiting.Reoperation to reposition or remove the device may be required.Other adverse events considered related to the lap-band system that occurred in fewer than 1% of subjects included: esophagitis, gastritis, hiatal hernia, pancreatitis, abdominal pain, hernia, incisional infection, infection, redundant skin, dehydration, gi perforation, diarrhea, abnormal stools, constipation, flatulence, dyspepsia, eructation, cardiospasm, hematemesis, asthenia, fever, chest pain, incision pain, contact dermatitis, abnormal healing, edema, paresthesia, dysmenorrhea, hypochromic anemia, band leak, cholecystitis, esophageal dysmotility, esophageal ulcer, esophagitis, port displacement, port site pain, spleen injury and wound infection.

Event Description

Reported as: a patient with the lap-band system was reported to have been "not tolerating fluids" and the band was emptied.The physician then repositioned the lap-band and defilled to 0cc intraop.The patient "continues not to keep fluids down later that day [was sent to the hospital] for dehydration.Possible repositioning, unbuckling or replacement." the band was repositioned and it was reported there were no issues.The patient presented the next day as they were not tolerating fluids.A ct scan was performed and there was no obvious leak of contract from stomach.The next day the patient had their lap-band removed.It was reported upon removal, there was an "abscess noted area of micro perf near band - patch of omentum.".

• Brand Name: LAP-BAND AP STANDARD WITH ACCESS PORT I
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. captial 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 ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5735860
• MDR Text Key: 47743141
• Report Number: 3006722112-2016-00160
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/19/2016
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 2653528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2014
• 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: 54 YR
• Patient Weight: 89