MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Codes	Collapse (1099); Migration or Expulsion of Device (1395); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2017, with the implantation of an afx bifurcated stent graft and an afx vela suprarenal stent.On (b)(6) 2024, it was reported that the patient was diagnosed with a type ib endoleak and an endoleak of indeterminate origin, possibly a type 3b or type ia endoleak.An angiographic computed tomography (ct) scan revealed distal migration and a significantly kinked vela suprarenal and proximal migration of the afx bifurcated stent graft within a 110mm diameter abdominal aortic aneurysm.On (b)(6) 2024, the patient underwent a re-intervention during which the physician implanted an afx2 bifurcated stent graft and two afx limb stent grafts.It was reported that the endoleak was not resolved.The final status of the patient remains unknown, as this information was not made available to endologix.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix's operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good faith efforts to retrieve the device related to the reported adverse event/incident, as well as the associated medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination required for device identification confirms that the device was 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 have contributed to the reported adverse event/incident.The device was not returned to endologix for evaluation, as 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 buckled afx vela suprarenal, type iiib endoleak of the afx vela suprarenal, type ib endoleak of the left common iliac artery, type ia endoleak (persistent) and additional endovascular procedure complaints are confirmed.The migration of the proximal extension and open repair procedure complaints are unconfirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The buckling of the afx vela suprarenal likely contributed to the type iiib endoleak.The angulation likely contributed to the reported buckling of the proximal extension; however, it is unclear if there was angulation in the infrarenal and juxtarenal aorta at the time of index.The type ia endoleak was likely due to the reported migration; however, the migration could not be confirmed due to a lack of comparative imaging.The type ia endoleak was still present post-reintervention on (b)(6) 2024, as seen on the computed tomography scan dated (b)(6) 2024.The final patient status was not reported.No additional investigation of this reported adverse event/incident is planned at this time.However, should any additional information relevant to the investigation 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: b5: describe event or problem - updated.G3: awareness date - updated.H6: health effect - impact code - remove 4614.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 on (b)(6) 2017, with the implantation of an afx bifurcated stent graft and an afx vela suprarenal stent.On (b)(6) 2024, it was reported that the patient was diagnosed with a type ib endoleak and an endoleak of indeterminate origin, possibly a type 3b or type ia endoleak.An angiographic computed tomography (ct) scan revealed distal migration and a significantly kinked vela suprarenal and proximal migration of the afx bifurcated stent graft within a 110mm diameter abdominal aortic aneurysm.On (b)(6) 2024, the patient underwent a re-intervention during which the physician implanted an afx2 bifurcated stent graft and two afx limb stent grafts.It was reported that the endoleak was not resolved.The patient was referred to another hospital, where they underwent open surgery.The patient's final status was reported as recovering well.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix's operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good faith efforts to retrieve the device related to the reported adverse event/incident, as well as the associated medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination required for device identification confirms that the device was 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 have contributed to the reported adverse event/incident.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the buckled afx vela suprarenal, type iiib endoleak of the afx vela suprarenal, type ib endoleak of the left common iliac artery, type ia endoleak (persistent) and additional endovascular procedure complaints are confirmed.The migration of the proximal extension and open repair procedure complaints are unconfirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The buckling of the afx vela suprarenal likely contributed to the type iiib endoleak.The angulation likely contributed to the reported buckling of the proximal extension; however, it is unclear if there was angulation in the infrarenal and juxtarenal aorta at the time of index.The type ia endoleak was likely due to the reported migration; however, the migration could not be confirmed due to a lack of comparative imaging.The type ia endoleak was still present post-reintervention on august 15, 2024, as seen on the computed tomography scan dated september 11, 2024.The patient's final status was reported as recovering well.No additional investigation of this reported adverse event/incident is planned at this time.However, should any additional information relevant to the investigation become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: d2: common device name - updated d4: model number - updated d4: lot number - updated d4: expiration date - updated d4: unique identifier (udi) number - updated h4: device manufacture date - updated h10/h11 - additional manufacturer narrative/corrected - updated.
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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the buckled afx vela suprarenal, type iiib endoleak of the proximal cuff, type ib endoleak of the left common iliac artery, type ia endoleak (persistent) and additional endovascular procedure complaints are confirmed.The migration of the proximal extension and open repair procedure complaints are unconfirmed.This is moderately consistent with the reported adverse event/incident.User or procedure relatedness of this complaint could not be determined.Procedure related harms could not be determined.The buckling of the afx vela suprarenal proximal extension likely contributed to the type iiib endoleak.The angulation likely contributed to the reported buckling of the proximal extension.It is unclear if there was angulation in the infrarenal and juxtarenal aorta at the time of index.The type ia endoleak was likely due to the reported migration; however, the migration could not be confirmed due to a lack of comparative imaging.The patient's final status was reported as recovering well.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: b5: describe event or problem - updated.B6: relevant tests and lab data - updated.H6: investigation finding codes - remove 4247.H6: investigation conclusion codes - remove 4315.H10/11: additional manufacturer narrative: updated.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2017, with the implant of an afx bifurcated stent graft and an afx vela suprarenal stent.It was reported on (b)(6) 2024, that the routine angiographic computed tomography (ct) scan identified distal migration, significant kinking of the afx vela suprarenal and proximal migration of the afx bifurcated stent graft with the abdominal aortic aneurysm at a 110mm diameter.There was a type ib endoleak and an endoleak of indeterminate origin, possibly a type 3b or type ia endoleak.On (b)(6) 2024, reintervention was performed with the implant of a (non-endologix) nexus 34x125mm tube, an afx2 bifurcated stent graft and two afx limb stent grafts.It was reported that the endoleak was not resolved.The patient was transferred to klinikum nürnberg süd on (b)(6) 2024, where the patient was converted to an open surgery and all devices were explanted.The patient's final status was reported as recovering well.

• 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: 20126603
• Report Number: 3011063223-2024-00127
• Device Sequence Number: 7482616
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)200329
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 03/22/2020
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1671484-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/11/2024; Not provided; 12/03/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/08/2024; 11/13/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT LOT# 1677935015.; AFX VELA SUPRARENAL LOT# 1671484010.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Unknown