MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an endovascular aneurysm repair on (b)(6) 2020 with an afx2 bifurcated stent graft and an afx vela suprarenal being implanted.On (b)(6) 2023 coil embolization of the inferior mesenteric artery embolization was performed to treat a type ii endoleak.On (b)(6) 2024, reintervention was performed to treat a type ii endoleak with the implant of an additional afx vela suprarenal.The endoleak was observed at the bottom of the first segment from the proximal edge of the initially implanted afx vela suprarenal.Final angiography post balloon touch-up showed that the endoleak had disappeared.On (b)(6) 2025 a suspected type iiib endoleak around the distal end of the vela suprarenal was observed.Two days later, the intraoperative angiography showed a type iiib endoleak.A pigtail catheter was inserted into the graft to prevent the guidewire from entering the endoskeleton.The pigtail catheter was advanced outside the afx2 bifurcated stent graft due to suspicions that the graft had been damaged and that there was already significant graft perforation through which the pigtail catheter could pass.The pigtail catheter was pulled back inside the graft and advanced to the proximal side.The guidewire was inserted in the catheter where the new afx2 bifurcated stent graft was implanted.Touch-up was performed.The final angiogram confirmed that the type iiib endoleak disappeared, and the procedure was completed.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.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 type iiib endoleak and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.Intraoperative advancement of the pigtail catheter beyond the stent could have caused a graft puncture, resulting in a procedure-related type iiib endoleak.However, the presence of a pre-existing type iiib endoleak prior to catheter placement cannot be definitively excluded.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.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.Corrections: b6: relevant tests and lab data has been updated g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.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 type iiib endoleak and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.No contributing factors were identified.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.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.Corrections: b5: describe event or problem: updated.D1: product family: updated.D2: common device name: updated.D4: model number: updated.D4: lot #: updated.D4: lot expiration date: updated.D4: udi #: updated.D10: therapy dates and concomitant product: updated.G3: date received by manufacturer: updated.H4: release date: updated.H10/11: additional manufacturer narrative: updated.
Event or Problem Description
The patient was treated for an endovascular aneurysm repair on (b)(6)2020 with an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal being implanted.On (b)(6)2023 coil embolization of the inferior mesenteric artery embolization was performed to treat a type ii endoleak.On (b)(6)2024, reintervention was performed to treat a type ii endoleak with the implant of an additional afx vela suprarenal.The endoleak was observed at the bottom of the first segment from the proximal edge of the initially implanted afx vela suprarenal.Final angiography post balloon touch-up showed that the endoleak had disappeared.On (b)(6)2025 a suspected type iiib endoleak around the distal end of the afx vela suprarenal.At reintervention on (b)(6)2025, angiography confirmed the type iiib endoleak was in the afx2 bsg.A pigtail catheter was advanced outside of the afx2 bsg and inserted into the existing hole of the afx2 bsg to prevent the guidewire from entering the endoskeleton.The pigtail catheter was pulled back inside the graft and advanced proximally.The guidewire was inserted in the catheter and a new afx2 bsg was implanted.Touch-up was performed.The final angiogram confirmed that the type iiib endoleak disappeared, and the procedure was completed.

• 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: 22202410
• Report Number: 3011063223-2025-00111
• Device Sequence Number: 7644005
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)230325
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 03/25/2023
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2343154-002
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 08/21/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/11/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2336305006.; AFX VELA SUPRARENAL, LOT # 2811287008.; AFX VELA SUPRARENAL, LOT # 2811287008.; AFX2 BIFURCATED STENT GRAFT, LOT # 2343154-002.; UNK COILS (TREATMENT DEVICE).; UNK COILS (TREATMENT DEVICE).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male