MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain 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 an afx bifurcated stent graft.Approximately three (3) years post initial implant on a follow-up ct scan there was a possible type iiib endoleak observed.No intervention has been performed at this time.There has been no additional patient sequalae reported at this time.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; type iiib endoleak.The root cause for the reported events could not be identified.The manufacturing records confirm that the lots met all requirements prior to release.Device remains implanted in the patient and was not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7799691
• Report Number: 2031527-2018-00671
• Device Sequence Number: 11317157
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)180113
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/24/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1310989-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 08/29/2019
• 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: AFX-LIMB STENT GRAFT-LOT-1252606-017
• Outcome Attributed to Adverse Event: Other