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

Model Number	BA25-80/I13-40
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	12/12/2017
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
On (b)(6) 2015, the patient was initially implanted with a bifurcated stent and a suprarenal extension.On (b)(6) 2017, endologix was made aware of a type 3b endoleak.The physician elected to reline the initial device with ovation devices to resolve this leak.The patient was reported in stable condition 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 able to find substantial evidence to support the following reported events of a type 3b endoleak of the main body, a secondary endovascular procedure and that the patient is in stable condition.Additionally clinical was able to find substantial evidence to support to the following additional findings of non-endologix stents implanted at unknown date prior to the endologix stents and aortic stenosis (50%) intra stent mural thrombu.The most likely cause of the compromised stent graft integrity of the main body was the pre-existing non endologix stent within the iliac artery.The most likely cause of the stenosis could not be determined however, the presence of an endoleak in the distal stent likely contributed to this condition.The patient was discharged home in stable condition on the first post-operative day.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7167414
• Report Number: 2031527-2018-00013
• Device Sequence Number: 1890645
• Product Code: MIH
• UDI-Device Identifier: 00818009010179
• UDI-Public: (01)00818009010179(17)170926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1278524-011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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 # 1346576-007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR