MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Codes	Leak/Splash (1354); Stretched (1601)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/23/2018
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 implant, sac growth has been reported with no visible endoleak.The physician elected to reline the original implant with another bifurcated stent graft and a suprarenal stent graft extension.The physician also placed several coils in the aneurysm sac.The patient was reported as stable post secondary procedure.As of the date of this report, 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 able to find substantial evidence to support the following reported event of sac growth.Clinical also found the following additional findings of stent cage dilation of both the bifurcated stent graft (main body) and the suprarenal stent graft extension (cuff).Event relatedness, procedure related harms and the final patient condition could not be determined with the medical available for review.A separate mdr will be filed for the stent cage dilation of the cuff (suprarenal stent graft extension).No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Event or Problem Description
At the completion of the clinical assessment on (b)(6) 2018, clinical was able to find substantial evidence to support the following additional findings of stent cage dilation of both the bifurcated stent graft (main body) and the suprarenal stent graft extension (cuff).A separate mdr will be filed for the stent cage dilation of the cuff (suprarenal stent graft extension).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8097855
• Report Number: 2031527-2018-00877
• Device Sequence Number: 14151050
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)170708
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: Health Professional
• Device Expiration Date: 07/08/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251901-023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/19/2019
• 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: SUPRARENAL EXTENSION, LOT # 1260326016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR