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

Model Number	BEA28-70/I16-30
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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
Primary procedure was performed on (b)(6) 2016.The patient was implanted with an afx2 bifurcated stent and an afx vela suprarenal.On (b)(6) 2018, the patient presented emergently with an endoleak type 3a.Reportedly, the physician noted it appeared that the graft migrated (lost overlap), and eventually disconnected.During the week of (b)(6) 2018 (the exact date was not provided) the patient was relined with a non-endologix device.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical assessment confirmed the type iiia endoleak of the cuff and main body with complete component separation.The migration complaint is unconfirmed due to a lack of relevant medical imaging.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.There were no contributing factors identified.Based on the information provided a root cause could not be determined for the reported events.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7669885
• Report Number: 2031527-2018-00582
• Device Sequence Number: 11423955
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)170311
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 03/11/2017
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 1355224011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: AFX VELA SUPRARENAL (LN 1252081002); AFX VELA SUPRARENAL (LN 1252081002)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR