MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-110/I16-30
Medical Device Problem Codes	Fracture (1260); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	01/04/2024
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 afx with duraply.H3 other text : device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft, a suprarenal aortic extension and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately eight (8) years post initial procedure, during a routine follow up, the patient was found to have aneurysm enlargement with no identifiable endoleak.The originally implanted stent grafts were relined with an afx2 bifurcated stent graft, a suprarenal aortic extension and an infrarenal aortic extension.It was reported this secondary procedure went well and there was no identifiable endoleak after the 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.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 aneurysm enlargement of 14mm, the indeterminate endoleak and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest stent fracture seen intraoperatively on angiogram (described as marker ring of afx graft) occurred that was not included in the event as reported.The stent fracture was discovered during review of the operative report dated 24 january 2024.It was reported that the marker ring of previous graft was broken.It is unclear what was meant by the marker ring, possibly referring to the fabric line of one of the proximal extensions but that could not be conclusively determined.The operative reported stated no endoleak identified, however later in the report it stated fracture was possible source of endoleak.The indeterminate endoleak is confirmed taking into account the 14mm sac growth.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were 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 afx with duraply.

• Brand Name: AFX
• 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: 18588552
• Report Number: 3011063223-2024-00009
• Device Sequence Number: 7159835
• Product Code: MIH
• UDI-Device Identifier: 00818009014160
• UDI-Public: (01)00818009014160(17)171015
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 10/15/2017
• Device Model Number: BA28-110/I16-30
• Device Lot Number: 1283282012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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: VELA INFRARENAL AORTIC EXTENSION, LOT # 1252540001.; VELA SUPRARENAL AORTIC EXTENSION, LOT # 1449834002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male