MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND AP STANDARD W/ ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2240

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Dysphagia/ Odynophagia (1815); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Malaise (2359)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Unknown taper.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.A review of the device labeling notes the following: precautions: over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation.Anti-inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti-inflammatory drugs, should be used with caution.The use of such medications may be associated with an increased risk of erosion.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 there is a risk of band erosion into the stomach tissue.Erosion of the band into the 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.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 reported the device "eroded a hole in the stomach and migrated to the liver." patient noted that after placement they experienced pain and couldn't swallow.Patient was informed that during the placement procedure the physician had filled the band.Patient informed physician that they didn't feel right, had no restrictions with meals.When the physician did a fill the patient couldn't feel it.Although it was noted when the physician removed the fill the same amount of saline was removed that was put in.Patient later had esophagitis.When a physician removed the device it was observed the lap-band was serving as a patch and a hole was noted.The patient had to spend 2-3 days in the hospital to recover from the procedure.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT I
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: kristin wielenga ; 1001 calle amanecer; san clemente, CA 92673
• MDR Report Key: 8709902
• MDR Text Key: 148405439
• Report Number: 3013508647-2019-00034
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020183
• UDI-Public: 10811955020183
• 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
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2016
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Device Lot Number: 2653516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 115