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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; GASTRIC ADJUSTABLE BAND

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RESHAPE LIFESCIENCES LAP-BAND SYSTEM; GASTRIC ADJUSTABLE BAND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Sepsis (2067); Hernia (2240)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
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.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.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.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.Obstruction of stomas has been reported as both an early and a late complication of this procedure.This can be caused by edema, food, improper initial calibration, band slippage, pouch torsion or patient non-compliance regarding choice and chewing of food.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.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Nausea and vomiting may occur, particularly in the first few days after surgery and when the patient eats more than recommended.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
The patient had revisional surgery after experiencing acute erosion.During the procedure, a hiatal hernia was repaired and adhesiolysis.During the post-operation, it was discovered the patient had an infected band and a micro-perforation which occurred during surgery causing the patient to become septic.
 
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Brand Name
LAP-BAND SYSTEM
Type of Device
GASTRIC ADJUSTABLE BAND
Manufacturer (Section D)
RESHAPE LIFESCIENCES
1001 calle amanecer
san clemente CA 92673
Manufacturer (Section G)
APOLLO ENDOSURGERY
building b 13.3
alajuela, cs
CS  
Manufacturer Contact
kristin wielenga
1001 calle amanecer
san clemente, CA 92673
MDR Report Key9558700
MDR Text Key189229347
Report Number3013508647-2020-00001
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P000008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2020
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
Initial Date Manufacturer Received 12/19/2019
Initial Date FDA Received01/07/2020
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 Number1
Patient Outcome(s) Required Intervention;
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