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

Model Number	BEA28-110/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately 1.5 years post initial procedure, a type iiib endoleak with an increased aneurysm sac (unknown diameter) were detected during routine follow-up.However, the exact date of event is unknown.The physician elected to treat the patient by implanting additional bifurcated afx2 device on (b)(6) 2019.The endoleak was confirmed resolved and the patient is reportedly in stable condition.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The type iiib endoleak with sac growth complaint is unconfirmed due the lack of the relevant medical information.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms for this complaint could not be determined.The final patient status was reported being stable post the secondary endovascular procedure.Unable to identify the contributing factors for the reported event.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.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections: g1,2: contact office- name has been updated h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9109712
• Report Number: 2031527-2019-00427
• Device Sequence Number: 16640445
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)180630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 06/30/2018
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 1711468-016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 04/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL: 1743392-033
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR