MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, follow-up report will be submitted.Device iteration is afx2.Device remains implanted.
Event or Problem Description
The patient was initially treated for a left internal iliac artery aneurysm (iiaa) on (b)(6) 2022 with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal stent graft.At that time circumferential calcification stenosis was observed around the terminal aorta.A gore (non-endologix) excluder leg was implanted in the left external illiac artery (eia).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.It was reported that the patient complained of pain and a ct was taken on an unknown date in which thromboembolization of the left limb (afx2 limb to the gore leg) was identified.Blood flow to the lower limb appeared to be obtained from collateral circulation, so the patient is currently experiencing intermittent claudication.The patient is currently being monitored while an intervention is being discussed.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 found the thrombosis (with resultant occlusion) of the left iliac stent is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest there was left common iliac artery occlusion and stent buckling of the main body.These findings were discovered during review of the computed tomography scan dated (b)(6) 2024.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The procedure is outside the indications of use (off-label) due to the use of adjunctive devices (gore excluder leg) not compatible with afx system per the ifu.The final patient status was reported as being monitored.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.Corrections:.G3: awareness date ¿ 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: 19480734
• Report Number: 3011063223-2024-00086
• Device Sequence Number: 12796812
• Product Code: MIH
• UDI-Device Identifier: 00818009015099
• UDI-Public: (01)00818009015099(17)250217
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2024

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: 02/17/2025
• Device Model Number: BEA22-90/I20-30
• Device Lot Number: 2550808005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 VELA SUPRARENAL (LN2562285001); GORE (NON-ENDOLOGIX) EXCLUDER LEG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male