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

Model Number	BA22-90/I16-30
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it is not available for return.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 informed of an explant on a patient due to possible stent graft infection.The patient's ax2 main body and suprarenal proximal extension were removed on (b)(6) 2017.No other information was provided regarding patient condition post op explant.
Additional Manufacturer Narrative
Based on the final report received from (b)(6), it was concluded that there were no device failure.Since the patient developed the infection one (1) year post evar, the infection was most likely due to bacteria gaining entry into the body from external factors.The type of bacteria could not be determined and the device investigation was not performed, so the root cause could not be determined.The review of manufacturing lot confirmed all devices met specifications prior to release.The devices explanted were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.Correction: patient information: (sex), event or problem.
Event or Problem Description
A final report received from b)(6) concluded that since the patient developed the infection one (1) year after evar, the mostly likely cause was due to bacteria gaining entry into the body from external factors.The type of bacteria could not be determined and the device investigation was not performed, so no root cause could be determined.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7267438
• Report Number: 2031527-2018-00084
• Device Sequence Number: 19175626
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)200213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 02/13/2020
• Device Model Number: BA22-90/I16-30
• Device Catalogue Number: F00757
• Device Lot Number: 1654352001
• 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: 01/18/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/25/2018
• 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: SUPRARENAL EXTENSION, LOT 1596548005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR