MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INTRARENAL EXTENSION

Model Number	A28-28/C95-O20 V
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	04/01/2024
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.The reported adverse event/incident was identified by endologix through an ongoing review of industry relevant journal articles where patient related outcomes are presented anonymously, and patient specific device information is unavailable.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 device was not returned to endologix for evaluation because the device remains implanted in the patient.A clinical evaluation of the adverse event/incident could not be completed as the reported event was found during publication review where the patient information is anonymous.Device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.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 h3 other text : device remains implanted.
Event or Problem Description
Journal article okubo renal rescue after inadvertent coverage during endovascular aneurysm repair reported that a 75-year-old man had undergone evar for an aaa at another hospital 3 years before admission and was followed up at our outpatient clinic.He was in a frail state after a brain hemorrhage and had a history of paroxysmal atrial fibrillation and hypertension, in addition to delirium after the previous evar.The afx endovascular aaa systems bea25-90/i16-30 and a28-28/c95- o20 v (endologix) were used in the previous surgery.Plain computed tomography (ct) revealed an increase in the aneurysm diameter over time (50 mm at the first visit and 55 mm before admission) and migration of the proximal extension to the distal region.Contrast-enhanced ct revealed a type ia endoleak from the dorsal side (fig 1).The proximal neck had no calcification or thrombus, and the length and diameter were 18mm and 25 mm, respectively.The neck aneurysm angulation was 55_.Endovascular treatment was considered appropriate due to the patient¿s clinical history, and an aorfix proximal extension (lombard medical) was added because of its purported ability to accommodate neck flexion effectively.The proximal extension diameter was selected as 27 mm based on the proximal neck diameter.The surgery was performed by a cardiovascular surgery specialist under general anesthesia using a percutaneous technique and included using the right common femoral artery for the proximal extension, with the aid of a curved ultra-stiff guidewire (cook medical) and the left artery for contrast.Proximal extension was deployed after positioning with contrast (fig 2, a).After deployment, the contrast revealed right renal artery occlusion.It was believed that the ventral side of the fish mouth shape covered the renal artery due to the inadequate angle of view (fig 2, b).Renal artery reconstruction was initially attempted using stent placement.First, a 20f sheath (dryseal; w.L.Gore & associates) was inserted from the right common femoral artery, and a guiding sheath (parent plus 60; medikit) was inserted from the left common femoral artery.Although the guidewire was passed into the right renal artery using a guiding catheter, stent insertion was difficult because of the poor backup force.Due to concerns regarding the renal ischemia time, a 0.035-in.Guidewire (radifocus; terumo corp) was advanced from the left common femoral artery to the outside of the proximal extension and near the right renal artery, where a 6 _ 40-mm balloon catheter (ultraverse; becton dickinson) was expanded to create a gap around the ostium to ensure blood flow to the renal artery (fig 3, a).Contrast administration after balloon dilation showed restored blood flow to the renal artery, and the time after proximal extension placement was 30 minutes.A steerable sheath (agilis nxt; abbott cardiovascular) was then inserted through the 20f sheath, in which the stiff wire was already inserted.The tip was bent to match the angle of the renal artery, and a 0.014-in.Guidewire was inserted into the right renal artery through the gap (fig 3, b).Delivery of a 6 _ 18-mm stent (express sd; boston scientific) was favorable and deployed with balloon dilation of the proximal extension.After stent placement, the proximal extension portion covering the renal artery was displaced to the distal edge of the stent.The blood flow of the renal artery was fully recovered (fig 4), and there was no evidence of an endoleak in the aneurysm.The postoperative course was uneventful.Contrast-enhanced ct revealed no structural stenosis of the renal arteries (fig 5) or evidence of endoleaks.Postoperative ultrasound revealed no renal artery stenosis, and blood tests revealed no signs of renal dysfunction.The patient was discharged on postoperative day 11.Six months postoperatively, the patient was doing well, with no aneurysm enlargement or renal function deterioration.Doi.Org/10.1016/j.Jvscit.2023.101411.Note: this is being reported to capture the post-operative, aneurysm enlargement; type ia endoleak; implant migration.The date of event has been estimated based on the information available in the journal article.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.The reported adverse event/incident was identified by endologix through an ongoing review of industry relevant journal articles where patient related outcomes are presented anonymously.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 device was not returned to endologix for evaluation because the device remains implanted in the patient.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.The final patient status was reported as doing well, with no aneurysm enlargement or renal function deterioration.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.Correction: has been updated.

• Brand Name: AFX
• Common Device Name: VELA INTRARENAL EXTENSION
• 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: 19394916
• Report Number: 3011063223-2024-00076
• Device Sequence Number: 20569341
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)220618
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 06/18/2022
• Device Model Number: A28-28/C95-O20 V
• Device Lot Number: 2260751012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: AFX2 BIFURCATED STENT GRAFT: LOT# 2276801006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male