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

Model Number	BA28-90/I16-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/09/2018
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, endologix was made aware by a rep who was called by a physician today to review a cta for a patient that had an initial implant procedure done on (b)(6) 2015.It was reported that patient's aaa was increasing in size and physician was questioning if there is a type 3.From looking at the cta, the patient original device had a short proximal neck.The proximal neck looks to have disease progression with enlargement of the aorta at the level of right renal measuring 3.9x3.5.No obvious type 1a seen, but suspected.Overlap of components looks good and stable.Rep will discuss cta in further detail with physician at a later time and what he plans to do for patient.Patient is doing well and stable and being monitored.
Additional Manufacturer Narrative
A device failure could not be determined due to a lack of any medical records or imaging, as well as procedure related harms and the final patient disposition.Clinical was unable to confirm the reported indeterminate endoleak and sac growth.There have been no further reports of negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.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: 7397942
• Report Number: 2031527-2018-00230
• Device Sequence Number: 10789789
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/09/2018

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: Physician
• Device Expiration Date: 03/23/2018
• Device Model Number: BA28-90/I16-30
• Device Catalogue Number: F00759
• Device Lot Number: 1265988009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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: VELA SUPRARENAL, LOT 1252472006
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR