MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; VELA INFRARENAL

Model Number	A28-28/C75V
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have not be returned for evaluation.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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) and infected aorta emergently (outside indications of use) with the afx abdominal aortic aneurysm stent.Approximately four (4) months post initial procedure, the patient presented with a crumpled proximal extension and type ia and iiia endoleaks.However, the exact date of event is unknown.The physician elected to treat the patient by explanting the devices on an unknown date, at which time thrombus between the components was noted.The patient is reportedly stable.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images but the request for medical records was denied and no response was received for the request of medical images.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned by the hospital after explant; therefore, an 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 afx with duraply.Corrections: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8983395
• Report Number: 2031527-2019-00406
• Device Sequence Number: 13544289
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)211115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2021
• Device Model Number: A28-28/C75V
• Device Lot Number: 2011804-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT: 1948664-010.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR