MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919); Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/08/2024
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 h3 other text: device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a suprarenal aortic extension to treat a fusiform shaped abdominal aortic aneurysm (aaa).Approximately eight (8) years post initial procedure, a follow-up computed tomography scan showed junction separation between the afx2 bifurcated stent graft and the vela aortic extension and there was a type 3a endoleak.The physician elected to implant an afx aortic extension between the existing stent grafts on (b)(6) 2024.The final angiogram showed that the endoleak was successfully resolved and the procedure was completed.The patient status was not reported.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 3a endoleak with a component separation of the bifurcated stent graft and the suprarenal extension is confirmed.There is no evidence of a type 3b endoleak.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harm for this complaint were identified.Unable to identify the contributing factors due to lack of the medical information.Unable to confirm the secondary endovascular procedure due to lack of the medical information.This is an off-label case due concomitant use with products outside the ifu (non-endologix in the left common iliac artery extension).The final patient status was not reported post the secondary endovascular 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.Device iteration is afx2 corrections: d10: concomitant product has been updated g3: awareness date 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 ; 8009832284
• MDR Report Key: 20891972
• Report Number: 3011063223-2024-00173
• Device Sequence Number: 15429245
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)190113
• 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: 2016
• 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): 12/02/2024

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: 01/13/2019
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 1285655015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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
• 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 SUPRARENAL AORTIC EXTENSION, LOT # 1474513002; AFX SUPRARENAL AORTIC EXTENSION, LOT # 1474513002; ILIAC (NON-ENDOLOGIX) LIMB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male