MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and two (2) afx vela suprarenal proximal extensions.Approximately forty-two (42) days post-initial procedure, the patient returned for a routine follow-up examination, during which a potential endoleak of type ia or type 2 was suspected.In order to ascertain the precise nature of the observed issue, the patient is scheduled to undergo an angiogram, a diagnostic procedure aimed at accurately identifying the presence and characteristics of the suspected endoleak.
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.Devices remain implanted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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 that the device was properly manufactured and released in accordance with the device master record.The review confirms that 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 that the type ia endoleak complaint is confirmed.The type ii endoleak is unconfirmed.The additional endovascular procedure (angiogram on 07/20/2023) complaint is confirmed.This is moderately consistent with the reported adverse event/incident.It was noted that there was angulation of the proximal neck; it is unclear if this contributed to the reported event.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status was discharged on the same day after a diagnostic aortogram on (b)(6) 2023.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.B5: describe event or problem - updated, g3: awareness date ¿ updated, h6: investigation finding codes - remove code 3233, h6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and two (2) afx vela suprarenal proximal extensions.Approximately forty-two (42) days post-initial procedure, the patient returned for a routine follow-up examination, during which a potential endoleak of type ia or type 2 was suspected.In order to ascertain the precise nature of the observed issue, the patient is scheduled to undergo an angiogram, a diagnostic procedure aimed at accurately identifying the presence and characteristics of the suspected endoleak.Additional information: an internal clinical evaluation confirmed that an additional endovascular procedure (diagnostic aortogram) was completed on (b)(6) 2023.The final patient status was discharged on the same day.The physician elected not to perform additional reintervention and instead will monitor the patient.

• 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: 17347566
• Report Number: 2031527-2023-00188
• Device Sequence Number: 6042106
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)240527
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 05/27/2024
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 2470395-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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 SUPRARENAL (B)(6); AFX2 BIFURCATED STENT GRAFT (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female