MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95V
Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
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.The device was not returned to endologix for evaluation because it was discarded by the user facility.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 1a endoleak, sac growth and surgical conversion complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the complaint could not be determined.Procedure related harms could not be determined.The final patient status was not reported.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 h3 other text : device was discarded at the hospital.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) and right common iliac artery aneurysm (ciaa) with implant of an afx2 bifurcated stent graft and an afx vela infrarenal proximal extension.It was reported that prior to the afx device implant the right internal iliac artery was occluded followed by implant of a gore (non-endologix) excluder on the right side, and an endurant (non-endologix) iliac limb on the left side.A viabahn (non-endologix) stent was then implanted in the right renal artery because there was a pre-existing dissection at the origin of renal artery.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.The afx2 was then implanted followed by the afx vela which was positioned below the renal artery.An angiogram was performed and showed type 3a endoleak between the afx2 and the endurant which required an afx limb to be implanted.The endoleak was resolved and the procedure was completed.Now, approximately five and a half (5.5) years post initial procedure, an open surgical procedure was performed due to sac enlargement and a type 1a endoleak.The physician elected to explant the vela and a portion of the afx2.The explanted devices were disposed off at the hospital.The afx2 limb portion of the device was unable to explanted; therefore, it was cut during the procedure and sutured to the vessel prosthesis.Suture leaks were observed; therefore, a gore (non-endologix) excluder was implanted from the renal artery to common iliac artery.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• 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: 18410202
• Report Number: 3011063223-2023-00059
• Device Sequence Number: 8724030
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)201208
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: 12/18/2020
• Device Model Number: A25-25/C95V
• Device Lot Number: 1765834002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX ILIAC LIMB, LOT # 1811491001; AFX2 BIFURCATED STENT GRAFT, LOT # 1783499007; GORE EXCLUDER, LOT # UNKNOWN; MEDTRONIC ENDURANT, LOT # UNKNOWN; VIABAHN STENT, LOT # UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male