MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024.The afx2 bifurcated stent graft delivery system was advanced from the left superficial femoral artery due to high calcification around the left groin.A gore excluder iliac extension was implanted in the left leg after occluding the left internal iliac artery with coils.This initial procedure is outside the indications of use (off-label) as the safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.The afx2 bifurcated stent graft and afx vela suprarenal were implanted from the left access.Angiography before balloon touch up showed endoleak around the terminal aorta.A type ib endoleak from the right limb and a type iiia endoleak from the left limb were suspected so balloon touch-up was performed on both limbs and junction at the left.The major endoleak was resolved, but a slight endoleak was still observed around the terminal aorta.The physician suspected a type iiib endoleak based on timing and location of endoleak and also suspects that it may be due to the suture holes as the leak volume is very little.The patient will be monitored with medication.Physician will elect to add afx2 if aneurysm size increases.
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 the intraoperative type ib endoleak and type iiia endoleak complaints are unconfirmed.The type iiib endoleak is unconfirmed; though, there was an endoleak visible on the angiogram video provided, it was unclear if the endoleak was a type iiib or type ii endoleak.This is not consistent with the reported adverse event/incident.It was reported that the left superficial femoral artery was used for access due to high calcifications, but it is unclear if this contributed to the reported event.The initial procedure is outside the indications of use (off-label) as the safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established (gore excluder left limb) and it is unclear if this contributed to the reported events.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final patient status was reported as being monitored.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: g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• 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: 19973556
• Report Number: 3011063223-2024-00125
• Device Sequence Number: 6964010
• Product Code: MIH
• UDI-Device Identifier: 00818009015099
• UDI-Public: (01)00818009015099(17)270129
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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 Model Number: BEA22-90/I20-30
• Device Lot Number: 2761239005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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 SUPRARENAL, LOT # 2764221009; GORE EXCLUDER ILIAC EXTENSION (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown