MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20V
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Malposition of Device (2616)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
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.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the movement of the most proximal extension of 7.1mm and an aneurysm enlargement of 10mm is confirmed.The indeterminate endoleak complaint is unconfirmed.The indeterminate endoleak complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.There was a reverse taper neck.It could not be conclusively determined if this contributed to the reported event.The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.Corrections: g3: awareness date ¿ updated h6: medical device problem codes - remove code 1395 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft, an afx vela infrarenal, and an afx vela suprarenal on (b)(6) 2022.Reportedly, the patient has a reverse taper neck and shaggy aorta.The afx2 bifurcated stent graft was implanted through the right access.The afx vela infrarenal was implanted immediately below the renal arteries.Balloon touch up was performed and the afx vela infrarenal migrated distally 1cm.There was no endoleak; however, an afx vela suprarenal was also implanted.The procedure was completed with no apparent endoleak.Reportedly on (b)(6) 2024, aneurysm diameter enlargement of approximately 1cm without apparent endoleak was confirmed during follow-up.There is adequate overlap between the afx2 bifurcated stent graft, afx vela infrarenal, and afx vela suprarenal; however, there is a possibility of type ia endoleak because there was the distal migration of the afx vela suprarenal after being implanted.This migration may have occurred due to a bad seal created between the afx vela infrarenal, and afx vela suprarenal and the aorta after the afx vela suprarenal was implanted on the bare stent of the vela infrarenal.Reintervention is planned; however, it has not yet been scheduled.Patient status was not provided.
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.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 20783107
• Report Number: 3011063223-2024-00167
• Device Sequence Number: 12012927
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)241027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 10/27/2024
• Device Model Number: A34-34/C80-O20V
• Device Lot Number: 2520173- 005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL LOT# 2256531-004.; AFX2 BIFURCATED STENT GRAFT LOT# 2246900-008.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male