MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/18/2019
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
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a type 3b endoleak was reported.As of the date of this report, an interventions has not been scheduled and there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed at the completion of the clinical assessment, clinical was unable to find substantial evidence to support the following event of a 3b endoleak due to lack of relevant medical records and/or imaging available for review.However; there was evidence of non-endologix left common iliac artery stents present prior to the initial endovascular aneurysm sealing system (evar) procedure.This is outside the indications of use (off - label) and is considered a contributing factor to this event however procedure related, device, user, procedure or anatomy relatedness could not be determined with the medical records and/or imaging available for review.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.
Event or Problem Description
Additional information: during the investigation of this event, evidence of non endologix left common iliac artery stents were present prior to the initial endovascular aneurysm sealing system (evar) procedure.This is outside the indications of use (off - label).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8493915
• Report Number: 2031527-2019-00170
• Device Sequence Number: 13846977
• Product Code: MIH
• UDI-Device Identifier: 00818009012623
• UDI-Public: (01)00818009012623(17)170929
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2019

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: Health Professional
• Device Expiration Date: 09/29/2017
• Device Model Number: BA28-70/I20-30
• Device Lot Number: 1279168008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2019
• Supplement Date Received by Manufacturer: 03/10/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPRARENAL EXTENSION, LOT 1201689027
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR