MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAGB SYSTEM 10CM; ADJUSTABLE GASTRIC BAND

Model Number	B-2220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to fda on (b)(6) 2018.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.If returned, visual examination may confirm or determine another taper type associated with this event.Device labeling addresses the reported event as follows: 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.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.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.Warnings: patients should be advised that the lap-band ap® 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 or Problem Description
Reported as: a patient with the lap-band system experienced pain at lap band port side and episodes of dysphagia.Device was removed.
Additional Manufacturer Narrative
Taper ii.Supplement #1: medwatch sent to fda on 12/28/2018.Device evaluation summary: a visual examination was performed on the returned lap-band with access port i and taper type ii.The band tubing was separated approximately 2.5" past the port tubing ss connector.The band tubing, port tubing, port taper, band ring and shell were noted to be discolored, as they were light brown in appearance.Needle marks were observed on the port septum and scratches were noted on one port hole.The band was separated in half approximately half way between the band buckle and band belt.The buckle strap was observed to be partially separated.An air leak test was performed, and leakage was noted from the band ring and shell where the band was separated in half.A fill inspection test was performed, and no blockage was noted when colored di water was passed through the port septum and tubing.Under microscopic analysis, both ends of the separated band ring and shell were noted to have a striated edges, consistent with damage from a surgical tool.Both ends of the partially separated portion of the buckle strap were observed to have striated edges, consistent with damage from a surgical tool.Both ends of the separated band tubing were observed to have striated edges, consistent with a surgical end cut to remove the device.Needle marks were noted on the port septum and on the port housing near the septum.Several non-penetrating nicks/marks were observed on one port hole.

• Brand Name: LAGB SYSTEM 10CM
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capitol of texas hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 8043935
• Report Number: 3006722112-2018-00272
• Device Sequence Number: 1464449
• Product Code: LTI
• UDI-Device Identifier: 10811955020169
• UDI-Public: 10811955020169
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2004
• Device Model Number: B-2220
• Device Catalogue Number: B-2220
• Device Lot Number: S02LB126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "LEVODEN"; ARIMIDEX; CRESTOR; FLEXERIL; LYRICA; NORVASC; TOPROL; ULTRAM; ZETIA; ZOFRAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 88