MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2016.Approximately eight (8) years post initial procedure, during a routine follow-up stent graft separation with aneurysm enlargement was noted.On (b)(6) 2024 after some diagnostic imaging, it was apparent that there was a type ia endoleak.The physician elected to treat the patient with implantation of an afx vela suprarenal stent graft.The type 1a endoleak was successfully resolved.The patient was reported as stable and being discharged.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2016.Approximately eight (8) years post initial procedure, during a routine follow-up stent graft separation with aneurysm enlargement was noted.On (b)(6) 2024 after some diagnostic imaging, it was apparent that there was a type ia endoleak.The physician elected to treat the patient with implantation of an afx vela suprarenal stent graft.The type 1a endoleak was successfully resolved.The patient was reported as stable and being discharged.Correction/update: the patient was initially implanted with an afx2 bifurcated stent graft for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2016.Approximately eight (8) years post initial procedure, during a routine follow-up there was aneurysm enlargement noted.On (b)(6) 2024 after some diagnostic imaging, it was apparent that there was a type ia endoleak.The physician elected to treat the patient with implantation of an afx vela suprarenal stent graft.The type 1a endoleak was successfully resolved.The patient was reported as stable and being discharged.
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 type ia endoleak and aneurysm enlargement are unconfirmed.The additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user procedure or anatomy relatedness of complaint cannot be determined.No procedure related harms or contributing factors could be identified.The final patient status was reported as discharged home on postoperative day one in stable condition.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 additional information/corrections: b5: describe event or problem: has been corrected/updated, d1: product family (primary): has been updated, d2: common device name (primary): has been updated, d4: model number (primary): has been updated, d4: lot # (primary): has been updated, d4: lot expiration date (primary): has been updated, d4: udi # (primary): has been updated, d10: therapy dates: remove row #1, g3: awareness date: has been updated, h4: release date (primary): has been updated, 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
• MDR Report Key: 20560077
• Report Number: 3011063223-2024-00149
• Device Sequence Number: 3200659
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)170920
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/26/2024

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: 09/20/2017
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1592089R009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2016
• 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: AFX2 BIFURCATED STENT GRAFT (LN 1592089-R009)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male