MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/21/2020
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.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with a type ia endoleak due to low placement (malposition) of the vela suprarenal device at the initial implant.The patient is reportedly stable but has refused treatment.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.However it was reported that this type 1a endoleak was most likely due to low placement (malposition) of the vela suprarenal stent graft during the initial implant.The patient was reported as stable and has refused treatment.Endologix is currently investigating the root cause of all report events related to leakage from the sheath.Currently a root cause has not been identified.Endologix will continue to investigate and monitor this and similar adverse events/incidents.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10997085
• Report Number: 2031527-2020-00369
• Device Sequence Number: 13647588
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)220625
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2020

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: 06/25/2022
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 2265206-016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2020
• Supplement Date Received by Manufacturer: 11/21/2020
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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: AFX2 BIFURCATED STENT GRAFT, SN (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR