MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAP-BAND AP LARGE W/ ACCESS PORT I; ADJUSTABLE GASTRIC BAND

Model Number	B-2245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Regurgitation (2259)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown taper.Medwatch sent to the fda on 04/20/2017.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.Without the device, the taper type is unknown.If returned, visual examination may determine the connector type associated with this event.Device labeling addresses the reported events as follows: 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.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 was reported to have "chronic dysphagia and gerd." device was explanted.
Additional Manufacturer Narrative
Taper ii.Supplement #1 - medwatch sent to the fda on 22-aug-2017.Device evaluation summary: the device was returned to apollo for analysis, and visual examination confirmed the connector type as taper ii.A visual examination was performed on the device, and noted scratches on the port.Needle marks were observed on the port septum.Brown discoloration was observed on the port septum, band ring and shell.Brown and black particles were observed on the port.White particles were observed on the inner surface of the band shell.A fill inspection test was performed and no blockage was observed.Under microscopic the port taper was noted to be partially separated near the port tubing junction.The separation had sharp edges.Analysis noted the ends of the separated pieces of band shell and ring were striated, consistent with device removal.A surgical end cut was observed on both the band and port tubing, consistent with device removal.

• Brand Name: LAP-BAND AP LARGE W/ ACCESS PORT I
• Common Device Name: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. captial tx hwy; bldg. 1 suite 300; austin TX 78746
• MDR Report Key: 6508748
• Report Number: 3006722112-2017-00119
• Device Sequence Number: 1330798
• Product Code: LTI
• UDI-Device Identifier: 10811955020190
• UDI-Public: (01)10811955020190(11)071204(17)091103(10)1525090
• 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: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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: 11/03/2009
• Device Model Number: B-2245
• Device Catalogue Number: B-2245
• Device Lot Number: 1525090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 08/22/2017
• 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: HYDROCODONE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Weight: 183