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

Model Number AB-20265

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Regurgitation (2259); Patient Problem/Medical Problem (2688)

Event Date 10/15/2017

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.Further information has been requested of the initial reporter clarity on the reported event and patient information.To date, no additional information has been received by apollo.A review of the device labeling notes the following: 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.Warnings: 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.The manufacturer of the lap-band ap adjustable gastric banding system has designed, tested and manufactured it to be reasonably fit for its intended use.However, the lap-band ap system is not a lifetime product and it may break or fail, in whole or in part, at any time after implantation and notwithstanding the absence of any defect.Causes of partial or complete failure include, without limitation, expected or unexpected bodily reactions to the presence and position of the implanted device, rare or atypical medical complications, component failure and normal wear and tear.In addition, the lap-band ap system may be easily damaged by improper handling or use.

Event Description

Reported as: a patient with the lap-band system was reported to have a device that is "not performing and has caused me severe health issues especially in the last 12 months." additional information noted faulty band removed.Removed in three pieces.

Event Description

Additional information noted by the physician: towards the end of 2017, patient started developing some mild reflux.A barium swallow showed a dilated distal esophagus and associated gastric pouch.In october, patient underwent a gastroscopy which noted some linear erosion from reflux.No comment was made about the malposition or slip.In general the patient had admitted very few symptoms over the time with the band.

Manufacturer Narrative

Supplement #2 - medwatch sent to the fda on 10/sep/2019.A review of the device labeling notes the following: 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 esophageal distension or dilatation has been infrequently reported.This is most likely a consequence of incorrect band placement, over-restriction or stoma obstruction.It can also be due to excessive vomiting or patient noncompliance, and may be more likely in cases of pre-existing esophageal dysmotility.Deflation of the band is recommended if esophageal dilatation develops.A revision procedure may be necessary to reposition or remove the band if deflation does not resolve the dilatation.Slippage and/or pouch dilatation of the band can occur.Gastroesophageal reflux, nausea and/or vomiting with early or minor slippage may be in some cases successfully resolved by band deflation.More serious slippages may require band repositioning and/or removal.If there is total stoma outlet obstruction that does not respond to band deflation, or if there is abdominal pain, then immediate re-operation to remove the band is indicated.Warnings: 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.

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.Brown particles were noted on the inner surface of the band shell and on the outer surface of the band buckle.As the port was not returned, a fill inspection test was not performed.An air leak test was performed, and no leakage was noted from the band or tubing.Under microscopic analysis, both ends of the separated band tubing were noted to have striated edges, consistent with damage from a surgical end cut to remove the device.Also under microscopic analysis, the end of the separated piece of port tubing was observed to have striated edges, consistent with a surgical end cut to remove the device.

• Brand Name: LAP-BAND AP SYSTEM LARGE
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 8659653
• MDR Text Key: 146699494
• Report Number: 3013508647-2019-00035
• 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,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

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
• Device Expiration Date: 01/29/2016
• Device Model Number: AB-20265
• Device Catalogue Number: AB-20265
• Device Lot Number: 2551523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 07/08/2019; 08/13/2019
• Supplement Dates FDA Received: 08/06/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 123