MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Material Puncture/Hole (1504); Obstruction of Flow (2423); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Thrombosis/Thrombus (4440); Clinical Endoleak (4843)
Date of Event	07/19/2022
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 implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Approximately six (6) years post initial procedure, on (b)(6) 2022, aneurysm enlargement with a type iiib endoleak of the afx vela suprarenal, and thrombosis in the afx2 bifurcated stent graft was identified.Reintervention was performed on (b)(6) 2023.The initially implanted stent grafts were re-lined with a medtronic (non-endologix) endurant stent.The results were successful, and the patient status was good.
Additional Manufacturer Narrative
The reported 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 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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device remains implanted.A clinical evaluation of the incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement, the type iiib endoleak, and reintervention is unconfirmed.The intrastent thrombosis (aortic stenosis) is confirmed.There was a clear endoleak seen on the still photo; however, it could not be determined what type of endoleak it was.Device, user, procedure or anatomy relatedness of incident could not be determined.Procedure related harms for this incident could not be determined.The superior stent margin of the proximal extension was at the level of the lowest left renal artery, approximately 20mm below expected landing zone.It is unclear if this was migration or suboptimal index procedure placement.The final patient status was reported as doing well following reline with non endologix device.No additional investigation of this reported 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 incidents.Device iteration is afx with duraply.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove code 1504.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.H7: if remedial action initiated - remove recall.H9: correction/removal report number - remove correction/removal report number.
Additional Manufacturer Narrative
The reported 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.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 incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiib endoleak and additional endovascular procedure (non endologix endograft) complaints are confirmed.The aneurysm enlargement is unconfirmed.The intrastent thrombosis (aortic stenosis) is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of incident could not be determined.Procedure related harms for this incident could not be determined.The superior stent margin of the proximal extension was at the level of the lowest left renal artery, approximately 20mm below the expected landing zone.It is unclear if this was migration or suboptimal index procedure placement.The final patient status was reported as discharged home in stable condition on postoperative day one.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.B6: relevant tests and lab data - updated, g3: awareness date ¿ updated, h10/h11: additional manufacturer narrative/corrected data - updated.

• 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: 16337580
• Report Number: 2031527-2023-00022
• Device Sequence Number: 20411927
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)190203
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2023

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: 02/03/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1461844021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 07/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/13/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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
• 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 (SN (B)(4)).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female