MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Codes	Leak/Splash (1354); Biocompatibility (2886)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2018, endologix was made aware of a patient with a continued sac growth, an indeterminate endoleak (possible type 1a/3a), and possible infection.Physician is planning on doing a repair, but no confirmed date has been provided.No further information received.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on lack of medical information received, there were no evidence to support the following reported events of an indeterminate endoleak, infection, and sac growth.Therefore, a root cause could not be determined due to a lack of relevant medical records and imaging.The final patient disposition could not be determined, and there have been no further reports of negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not be returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7497205
• Report Number: 2031527-2018-00416
• Device Sequence Number: 1705015
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)170311
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/11/2017
• Device Model Number: BEA28-70/I16-30
• Device Catalogue Number: F00820-22
• Device Lot Number: 1355224017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/20/2018
• 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: 70 YR