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

Model Number	BA25-90/I16-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is anticipated that the device remains in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
Primary procedure was performed on (b)(6) 2016, the patient was implanted with a afx bifurcated stent graft and a afx infrarenal aortic extension.Secondary procedure was performed on (b)(6) 2017, for an unknown reason.A afx vela suprarenal and afx vela infrarenal were implanted in the patient.No additional event or patient information is available.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; indeterminate endoleak (possible type ii or type iii).The physician conducted a secondary procedure to treat the undetermined endoleak and proximally extend renal stent placement.The manufacturing records confirm that the lots met all requirements prior to release.There have been no further reports of negative patient sequelae.The device remains implanted in the patient and is not available for evaluation.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7443835
• Report Number: 2031527-2018-00314
• Device Sequence Number: 19106170
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)171119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 11/19/2017
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1252261025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: AFX INFRARENAL AORTIC EXTENSION (LN 1379616006); AFX INFRARENAL AORTIC EXTENSION (LN 1379616006)
• Outcome Attributed to Adverse Event: Required Intervention