MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. LAP-BAND AP STANDARD W/ ACCESS PORT II; ADJUSTABLE GASTRIC BAND

Model Number	B-2260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Taper unknown.Should the device be removed, a visual examination may determine the connecter type associated with the reported events.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.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 lap-band hero clinical study had an adverse event of "abdominal pain, undetermined etiology".The patient was hospitalized and had "gallbladder workup, which was normal".Device remains implanted.
Additional Manufacturer Narrative
To date, apollo has not received the device.If returned, visual examination may confirm or determine the taper type associated with this event.
Event or Problem Description
Reported as: a patient in the apollo-001 lap-band adjustable gastric banding system lbmi clinical study had device removed.

• Brand Name: LAP-BAND AP STANDARD W/ ACCESS PORT II
• 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: 7273428
• Report Number: 3006722112-2018-00046
• Device Sequence Number: 1044533
• Product Code: LTI
• UDI-Device Identifier: 10811955020220
• UDI-Public: 10811955020220
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P000008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: Physician
• Device Expiration Date: 05/13/2017
• Device Model Number: B-2260
• Device Catalogue Number: B-2260
• Device Lot Number: 2738107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: MEDICATION FOR HYPERTENSION; MEDICATIONS FOR GERD; NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAIDS); ORAL/INJECTABLE STEROIDAL MEDICATIONS; MEDICATION FOR HYPERTENSION; MEDICATIONS FOR GERD; NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAIDS); ORAL/INJECTABLE STEROIDAL MEDICATIONS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR