MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I20-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The distal portion of the afx2 bifurcated stent graft and the proximal portion of the vela will be returned for evaluation.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an artificial prosthesis in 2013 (exact date is unknown).On (b)(6) 2022 the patient was implanted with an afx2 bifurcated stent graft and a vela suprarenal aortic extension for the treatment of pseudoaneurysm observed at the distal edge of the artificial prosthesis.On (b)(6) 2023, an open surgical procedure was performed because the pseudoaneurysm was enlarging.During the procedure endoleaks from suture holes were confirmed.The distal portion of the afx2 bifurcated stent graft from the bifurcation to the limbs was explanted.The proximal portion of the vela was also explanted with the proximal portion left in the patient and sutured to the newly implanted "y" shaped surgical graft.The explanted stent graft is available for return.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The explanted devices were returned to endologix and evaluation was completed.Endologix conducted a comprehensive assessment of the returned afx2 bifurcated stent graft, along with the proximal portion of the vela.The devices were securely packaged in a box and transported in a biohazard containment container, then double-bagged for safety precautions.Prior to evaluation, the devices underwent a decontamination process to eliminate any potential contaminants.Upon visual inspection of the afx2 bifurcated stent graft, punctures were observed where the stent/stent frame protruded on the distal portion of the stent graft.This finding corresponds to characteristics indicative of a type iiib endoleak.It is important to acknowledge the possibility that this damage may have occurred during the explant procedure.Similarly, the proximal portion of the vela underwent inspection, though identifying any issues was challenging due to the size of the explant.Nothing stood out significantly from the inspection of the vela explant.The reported damage (endoleak type iiib) was confirmed based on the identification of holes within the afx2 bifurcated stent's graft material.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 type 3b endoleak from the afx2 bifurcated stent graft and surgical conversion are confirmed.The aneurysm sac growth complaint is unconfirmed due to a lack of the medical information.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Unable to identify the contributing factors due to a lack of the medical information surrounding the event.The final patient status was not reported.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.H6: investigation type codes, remove code 4118; h6: investigation finding codes: remove code 3233; h6: investigation conclusion codes: 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: 18478077
• Report Number: 3011063223-2024-00005
• Device Sequence Number: 6923802
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)240204
• 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: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 02/04/2024
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 2423908005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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 # 2426112005.; ARTIFICIAL VESSEL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown