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

Model Number	BIFURCATED STENT GRAFT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/04/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
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 with sac growth was reported.An intervention was completed.The physician elected use non- endologix stents to resolve this event.The intervention was successful and the patient was reported as stable.
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 with sac growth was reported.An intervention was completed.The physician elected use non- endologix stents to resolve this event.The intervention was successful and the patient was reported as stable.Additional information: during our investigation, the reported type 3b endoleak was refuted, rather it was a type 1b endoleak from the left common iliac artery.
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 able to find substantial evidence to support the following events: the reported type 3b endoleak was refuted, rather there was a type 1b endoleak from the left common iliac artery.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined based off the medical records / imaging available for review.The final patient status was discharged on post operative day two home stable following a reported reline with a non endologix stent.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 corrections: h6: result code: remove code 3233.H6: conclusion code: remove code 11.H7: remove recall.H9: remove z-0006-2019.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9186966
• Report Number: 2031527-2019-00459
• Device Sequence Number: 19407692
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)171013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2017
• Device Model Number: BIFURCATED STENT GRAFT
• Device Lot Number: 1251907-016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2019
• Supplement Date Received by Manufacturer: 09/14/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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: VELA SUPRARENAL, LOT 1252486015
• Outcome Attributed to Adverse Event: Required Intervention