MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ruptured Aneurysm (4436); Embolism/Embolus (4438); Clinical Endoleak (4843)
Date of Event	05/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated with implant of an afx2 bifurcated stent graft, an afx vela suprarenal, an afx limb stent graft and an ovation ix extender.Approximately two (2) years post initial procedure, the patient emergently presented with abdominal pain.The physician identified a potential endoleak (indeterminate origin) during a computed tomography (ct) scan.The patient was transferred to another hospital for open surgery to repair endoleak.The patient was hemodynamically stable and expired due to unknown reason.Note: the afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
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 indeterminate endoleak was determined to be a type ia endoleak and a type iiib endoleak.The preexisting ruptured aorta, open surgical intervention and death complaints are confirmed.This is moderately consistent with the reported adverse event/incident.The initial procedure is off label due to concomitant product usage (ovation limb).The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.It is unclear if this contributed to the reported event.The superior stent margin of the main body was positioned at a 25.1° angulation, resulting in poor apposition between the main body and the proximal cuff.This could have contributed to the reported type ia endoleak.The patient had preexisting renal cell carcinoma with lung metastases.Both the underlying malignancy and treatment with immunotherapy could contributed to an increased risk of disseminated intravascular coagulation (dic).The preexisting rupture likely contributed to a hypercoagulable state that led to dic.The thrombus in the right atrium was likely a result of the hypercoagulable state associated with disseminated intravascular coagulation (dic).The thrombosis in the heart, combined with hypoxia, likely contributed to the development of pulseless electrical activity (pea), which ultimately resulted in the patient¿s death making this procedure related.The clinal assessment determined that there was aneurysm enlargement of 7.5mm that was not included in the event as reported.The aneurysm enlargement was discovered during review of the ct scan dated on (b)(6) 2025.The death is most likely anatomy related.Device, user, procedure or anatomy relatedness of the type ia and iiib endoleak complaints could not be determined.The complaint is most likely anatomy related.The procedure related harms are abnormal blood loss (from dic coagulopathy), embolism (blood clot right atrium), hemodynamic instability, cardiac arrest and death.The final patient status was reported as deceased during procedure.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: g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.H6: medical device problem codes: remove code 2993.

• 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
• MDR Report Key: 22063060
• Report Number: 3011063223-2025-00081
• Device Sequence Number: 7849466
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)240518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: 05/18/2024
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 2460585004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT, LOT#: 2403624003.; AFX VELA SUPRARENAL, LOT#: 2483805003.; OVATION IX EXTENDER, LOT#: FS102721-52.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male