MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND AP SYSTEM SMALL; ADJUSTABLE GASTRIC BAND ACCESS PORT

Model Number AB-20260

Device Problem Fluid/Blood Leak (1250)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Cramp(s) (2193)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, a visual examination may confirm or determine the taper type associated with this event.Review of the device labeling notes the following: precautions: it is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant.Care must be taken during band adjustment to avoid puncturing the tubing that connects the access port and band, as this will cause leakage and deflation of the inflatable section.Failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen.When adjusting band volume, take care to ensure the radiographic screen is perpendicular to the needle shaft (the needle will appear as a dot on the screen).This will facilitate adjustment of needle position as needed while moving through the tissue to the port.Failure to enter the port with the needle perpendicular to the port may cause damage to the access port and result in leaks.When adjusting band volume after the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum.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.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.Deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warnings: patients should be advised that the lap-band ap® 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.Patients must be carefully counseled on the need to report all vomiting, abdominal pain or other gastrointestinal or nutritional issues as these symptoms may indicate a condition not related to the lap-band® system.

Event Description

Reported as: a patient with the lap-band system was reported to have "tube come away from band.Patient experienced pain low down and moving from side to side, causing spasm and cramps.The pain at times was crippling, to the point patient was unable to get out of a chair until the spasm released." port was removed and band is still in place.

Manufacturer Narrative

Device evaluation summary: the device was returned to apollo, and a visual inspection was performed.White and yellow particulate matter was noted on one end of the separated band tubing.A leak test was performed; as the port was not received, only the returned piece of band tubing was tested.Air passed through one end of the band tubing with no leakage or blockage noted, indicating that the test had passed.Under microscopic analysis, one end of the separated band tubing was observed to have striated edges, consistent with a surgical end cut to remove the device.A portion of the opposite end of the separated band tubing was noted to have sharp edges.

Manufacturer Narrative

Unknown taper.

• Brand Name: LAP-BAND AP SYSTEM SMALL
• Type of Device: ADJUSTABLE GASTRIC BAND ACCESS PORT
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente 92673
• MDR Report Key: 8370891
• MDR Text Key: 141221943
• Report Number: 3013508647-2019-00002
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2015
• Device Model Number: AB-20260
• Device Catalogue Number: AB-20260
• Device Lot Number: 2429351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 05/08/2019
• Supplement Dates FDA Received: 04/10/2019; 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR