MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I20-40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and an ovation extender to treat an abdominal aortic aneurysm (aaa).Approximately 4 years post initial procedure during a routine follow up a type 3a endoleak was identified.Patient is pending a follow up angiogram and the physician is planning a re-intervention.
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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.
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 the reported type 3a endoleak (of the bifurcated stent graft and proximal aortic extension) with additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.While the initial procedure was off-label due to concomitant device usage, it is unclear if this contributed to the reported event.The final patient status was reported as doing well.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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and an ovation extender to treat an abdominal aortic aneurysm (aaa).Approximately 4 years post initial procedure during a routine follow up a type 3a endoleak was identified.Patient is pending a follow up angiogram and the physician is planning a re-intervention.Clarification: the initial implant procedure was outside the indications of use (off-label) due to adjunctive devices not compatible with the afx system per device ifu.Additional information: the physician elected to treat the patient by implanting one (1) afx2 bifurcated stent graft, one (1) afx vela infrarenal and one (1) afx vela suprarenal on 01 september 2022.The endoleak was successfully resolved and the patient tolerated the procedure well.

• 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: 15296028
• Report Number: 2031527-2022-00213
• Device Sequence Number: 14117995
• Product Code: MIH
• UDI-Device Identifier: 00818009014412
• UDI-Public: (01)00818009014412(17)190115
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 01/15/2019
• Device Model Number: BEA28-80/I20-40
• Device Lot Number: 1776266001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2018
• 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 LOT#1737146003; OVATION IX EXTENDER LOT#FS032118-02
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male