MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC LAP-BAND® SYSTEM 9.75 WITH ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number B-2210

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Unknown taper.Device labeling addresses the reported event as follows: precautions: 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.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.Unplanned deflation of the band may occur due to leakage from the band, the port or the connecting tubing.Warning: 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.

Event Description

Reported as: a patient with the lap-band system was reported to have been "evaluated for a lap band tubing leak." [patient] "felt there was no restriction and there was minimal fluid in [their] system.When saline was injected it did not return full volume.X-ray showed proximal tubing leak, which required laparoscopy to repair.Leak was too close to band to repair at laparoscopy." device was removed.

Manufacturer Narrative

Taper ii.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.Brown discoloration was observed on the port septum.Needle marks were observed on the port septum.Six non-penetrating nicks were noted on the band belt and buckle.A port leak test was performed and no leakage was observed.A fill inspection test was performed an no blockage was noted.An air leak test was performed and leakage from the band ring/shell where the band was noted to be separated from the belt was observed.Under microscopic analysis, the ends of the band ring/shell were noted to have striated edges, which is consistent with device removal activities.The port tubing and the band tubing were noted to have a striated end cut, consistent with device removal.

• Brand Name: LAP-BAND® SYSTEM 9.75 WITH ACCESS PORT I
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. capital 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, ; CS
• Manufacturer Contact: laura lebouef ; 1120 s. capital of texas hwy; bldg. 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 7049844
• MDR Text Key: 93433028
• Report Number: 3006722112-2017-00385
• Device Sequence Number: 1
• Product Code: LTI
• UDI-Device Identifier: 10811955020145
• UDI-Public: 10811955020145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/20/2008
• Device Model Number: B-2210
• Device Catalogue Number: B-2210
• Device Lot Number: 1329974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2006
• 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 Age: 44 YR
• Patient Weight: 93