MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA28-60/I16-40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2018
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
On (b)(6) 2018, the patient was implanted with a bifurcated stent to treat an abdominal aortic aneurysm.On (b)(6) 2018, endologix was made aware of a type 1a endoleak.A secondary procedure has been scheduled for sometime in (b)(6) 2018.There is no other information at this time.The patient was been reported as doing fine 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 confirm the following reported events of type 1a endoleak and a secondary procedure.Device, user, procedure, anatomy relatedness or procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be doing fine.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
Additional information: on 04/11/2018, the physician elected to implant an non- endologix (medtronic) cuff to resolve this endoloeak.The patient was reported as fine post-secondary procedure.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7458802
• Report Number: 2031527-2018-00380
• Device Sequence Number: 16424341
• Product Code: MIH
• UDI-Device Identifier: 00818009014474
• UDI-Public: (01)00818009014474(17)181122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 11/22/2018
• Device Model Number: BEA28-60/I16-40
• Device Lot Number: 1761588-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: Other; Required Intervention
• Patient Age: 78 YR