MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD WITH RAPIDPORT EZ; ADJUSTABLE GASTRIC BAND

Model Number	B-2360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rapidport ez strain relief.Medwatch sent to fda on 01/04/2017.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Based on the serial number provided, the connecter type is assumed to be a rapidport ez strain relief.Device labeling addresses the reported event as follows: precautions: during insertion of the calibration tube, care must be taken to prevent perforation of the esophagus or stomach.Do not push the tip of any instrument against the stomach wall or use excessive electrocautery.Stomach perforation or damage may result.Stomach perforation may result in peritonitis and death.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.Perforation of the stomach can occur.Death can also occur.Specific complications of laparoscopic surgery can include spleen damage (sometimes requiring splenectomy) or liver damage, bleeding from major blood vessels, lung problems, thrombosis, and rupture of the wound.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 in the (b)(6) clinical study "presented to the emergency room (er) with sudden sharp left upper quadrant pain and shortness of breath".Patient underwent emergency surgery for removal of lap-band due to "perforated stomach".

• Brand Name: LAP-BAND AP STANDARD WITH RAPIDPORT EZ
• 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: 6222072
• Report Number: 3006722112-2017-00003
• Device Sequence Number: 415489
• Product Code: LTI
• UDI-Device Identifier: 10811955020268
• UDI-Public: (01)10811955020268(11)150430(17)170430(10)2732143
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2016

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: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: B-2360
• Device Catalogue Number: B-2360
• Device Lot Number: 2732143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 73