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

Model Number	BA25-100/I20-40
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924)
Date of Event	10/11/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
During the initial implant of an afx on (b)(6) 2017, the main body was damaged and caused the graft to become stuck onto a previously placed graft in the middle of the aorta.After attempting to free the graft, the physician elected to perform an open conversion.The patient did not tolerate the procedure and expired 1 day procedure.
Additional Manufacturer Narrative
Clinical evaluations was unable to find substantial evidence to support the reported unable to deploy and explant of the device.Clinical evaluations was unable to find substantial evidence to support the reported death.Additionally there was evidence to reasonably support that at 2 months post implant there was and endoleak type ia, iiia, and ii.The most likely cause of the inability to deploy was intentional user error due to a cautionary product use condition of an attempt to revise a previous graft endovascularly.Procedure-related harms included: the death post an open conversion on the first post-operative day.The first observations of the endoleak were processed under pr (b)(4) and will not be addressed here.The cause of death could not be ascertained due to the lack of medical information surrounding the repair event.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Additional Manufacturer Narrative
Based upon the information available, the root cause of the reported event is unknown at this time.The device was not returned, therefore no physical evaluation was completed.The review of manufacturing lot confirmed all devices met specifications prior to release.There were no patient medical records or images available for review.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6679549
• Report Number: 2031527-2017-00577
• Device Sequence Number: 19095563
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)200403
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2018

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: 04/03/2020
• Device Model Number: BA25-100/I20-40
• Device Lot Number: 1672391-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017; 01/29/2018
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 06/29/2017; 02/15/2018
• 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: Death