MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation as the patient had an infection and the explanted device was discarded.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.Device iteration is afx2.H3 other text: device discarded by the hospital.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2024, with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.On (b)(6) 2024, the patient presented emergently with abdominal pain.A computed tomography angiogram was performed identifying that the aorta is infected around the afx graft implanted on (b)(6) 2024.The physician present on (b)(6) 2024, stated that the aorta was possibly infected to begin with and it has now worsened.Explantation of the devices and aortic repair was completed on (b)(6) 2024.The patient was stable post-procedure.
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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the infection of the aorta, aortic graft and surgical conversion with explant complaints are confirmed.This is consistent with the reported adverse event/incident.The complaint is likely user related due to the off-label use as the infection of the aorta (aortitis) was present at the time of the index procedure.Additionally, the safety and effectiveness of afx2 placed in the setting of an active infection has not been evaluated.The complaint is also likely anatomy related as the patient presented with abdominal pain consistent with aortic inflammation (aortitis).The aortitis was likely secondary to disseminated bacillus calmette-guérin.(bcg) therapy was administered as part of the treatment for bladder cancer (pre-existing condition).The development of aortitis was likely complicated by the presence of a penetrating aortic ulcer.It is unclear why there was an endovascular repair done on (b)(6) 2024.A surgical conversion was completed.The renal insufficiency was likely due to coverage of the left accessory renal artery during the repair.Procedure related harms are hemodynamic instability, abnormal blood loss, and renal insufficiency.The final patient status was reported as discharged to sub-acute rehabilitation on postoperative day 27, discharged hospital day 31 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.Corrections: g3: awareness date ¿ 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 ; 8009832284
• MDR Report Key: 20213345
• Report Number: 3011063223-2024-00136
• Device Sequence Number: 15254439
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)270222
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: BEA22-80/I16-40
• Device Lot Number: 2769588009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN: 2763636002).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male