MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I16-30
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Clinical Endoleak (4843)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela infrarenal.The stent grafts were implanted through the left access site.It was noted that the left common iliac artery (cia) was less than 30 mm in length.It was also noted that the afx was implanted floating from the aortic bifurcation.The procedure was completed without an endoleak; however, because only one stent length overlapped the aortic neck, a second vela infrarenal was implanted so that one stent length could be extended proximally.After balloon touch-up of the limb the procedure was completed.Approximately three and a half (3.5) years post initial procedure stent migration and shorter overlap between the stent grafts were seen.There was no confirmed endoleak.The patient is currently being monitored while an intervention is being discussed.
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 afx2.
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.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 adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the implant migration complaint (loss of overlap) is confirmed.This is consistent with the reported adverse event/incident.The superior stent margin of the main body is positioned in a sharp infrarenal angulation of 73.7° causing separation of the main body and proximal cuff.At index, the stent exhibited a straight configuration without any notable angulation- aortic remodeling.It is likely there was a type iiia endoleak, however that could not be conclusively determined due to the non-contrasted nature of the ct scan.The complaint is likely anatomy related.The additional endovascular procedure complaint is unconfirmed.Procedure related harms could not be determined.The final patient status was reported as stable and was discharged without any problems.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 afx2.Corrections: b5: describe event or problem has been updated g3: date received by manufacturer has been updated.H6: impact code: remove code 4614 h6: result code: remove code 3233 h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela infrarenal.The stent grafts were implanted through the left access site.It was noted that the left common iliac artery (cia) was less than 30 mm in length.It was also noted that the afx was implanted floating from the aortic bifurcation.The procedure was completed without an endoleak; however, because only one stent length overlapped the aortic neck, a second vela infrarenal was implanted so that one stent length could be extended proximally.After balloon touch-up of the limb the procedure was completed.Approximately three and a half (3.5) years post initial procedure stent migration and shorter overlap between the stent grafts were seen.There was no confirmed endoleak.On (b)(6) 2024 the reoperation was performed, the physician elected to reline using a gore excluder cuff (non-endologix).The patient was reported as being stable and was discharged without any problems.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 20408633
• Report Number: 3011063223-2024-00145
• Device Sequence Number: 6546010
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)230117
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 01/17/2023
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2324880007
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• 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 VELA INFRARENAL, LOT # 2311470005; AFX VELA INFRARENAL, LOT # 2313473007
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown