MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I20-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	08/02/2024
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 strata h3 other text : device remains implanted.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and ovation ix extender in the right limb to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure, during a routine follow up, a type ib, a suspected type ia endoleak was observed and the iliacs had enlarged.Intervention occurred on (b)(6) 2024 with the implantation of an afx limb stent graft, two (2) vela suprarenal's, and an ovation ix extender.It was reported that the endoleak was sealed and the patient is stable.Note: the safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and ovation ix extender in the right limb to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure, during a routine follow up, a type ib, a suspected type ia endoleak was observed and the iliacs had enlarged.Intervention occurred on (b)(6) 2024 with the implantation of an afx limb stent graft, a vela suprarenal, and an ovation ix extender.It was reported that the endoleak was sealed and the patient is stable.Note: the safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
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.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 type ib endoleak of the right common iliac artery, type ia endoleak, and right common iliac aneurysm enlargement complaints are unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest right common iliac artery occlusion (treated with left to right femoral bypass graft on (b)(6) 2024) occurred.The right common iliac artery occlusion was discovered during review of the operative report dated (b)(6) 2024.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to use of concomitant devices (right ovation limb extension).It is unclear if this contributed to the reported event.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.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 afx with strata.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• 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: 20032819
• Report Number: 3011063223-2024-00128
• Device Sequence Number: 15058777
• Product Code: MIH
• UDI-Device Identifier: 00818009012265
• UDI-Public: (01)00818009012265(17)190929
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• 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): 08/01/2024

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: 09/29/2019
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1595273012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX EXTENDER, LOT # FS081616-50.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown