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	12/05/2023
Type of Reportable Event	Serious Injury
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.Device iteration is afx2.H3 other text : device not provided for the investigation.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2018.During the procedure, an afx vela suprarenal was positioned just below the renal artery.However, during retrieval of the delivery system tip, the afx vela suprarenal migrated downward, necessitating the addition of another afx vela suprarenal.The procedure concluded successfully without any signs of endoleaks.A type ii endoleak (non-device-related failure) was detected on subsequent follow-up computed tomography (ct) images, although the exact timing of its occurrence is unknown.The patient was closely monitored in response.On (b)(6) 2023, another follow-up ct scan revealed an aneurysm enlargement and a possible endoleak originating from the main body.On (b)(6) 2024, open surgery was performed.The presence of a type iiib endoleak from suture holes, observed on both the front and back sides, and a type ii endoleak were confirmed.The afx2 stent graft was explanted, and vessel replacement was undertaken.The additional surgical procedure was successfully completed, and the patient's post-operative condition remained stable.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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 was 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.A clinical evaluation of the adverse event/incident could not be completed.No medical records or medical imaging relevant to the reported adverse event/incident were received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging, device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was reported as stable.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: 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: 18989256
• Report Number: 3011063223-2024-00047
• Device Sequence Number: 20883978
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)181120
• 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: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 11/20/2018
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 1759574-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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 1774624-006; AFX VELA SUPRARENAL 1929924-002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male