MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Separation Problem (4043); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/14/2022
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, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for a common iliac aneurysm with implant of an afx2 bifurcated stent graft, an afx vela infrarenal proximal extension and an afx limb stent graft distal extension.This procedure is outside the indications of use (off-label) due to the absence of an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, the physician treated the patient for a type iiia endoleak (of the right iliac limb) by implanting two (non-endologix) stents in the right common iliac artery.The final patient status was not indicated.This secondary intervention, completed on (b)(6) 2022, was discovered during clinical assessment to patient id (b)(6) (reference mfr.Report # 2031527-2023-00016).
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 iiia endoleak (of the right common iliac artery (rcia)) with component separation and secondary endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user-related due to the patient's off-label anatomy of the rcia (measured 3.8cm, and device ifu requirement is less than 2.5mm).Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported as being stable post re-intervention.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.
Event or Problem Description
The patient was initially treated for a common iliac aneurysm with implant of an afx2 bifurcated stent graft, an afx vela infrarenal proximal extension and an afx limb stent graft distal extension.This procedure is outside the indications of use (off-label) due to the absence of an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, the physician treated the patient for a type iiia endoleak (of the right iliac limb) by implanting two (non-endologix) stents in the right common iliac artery.The final patient status was not indicated.This secondary intervention, completed on 14 march 2022, was discovered during clinical assessment to patient id 60939 (reference mfr.Report # 2031527-2023-00016).Additional information: clinical assessment identified that complete component separation of the bifurcated stent graft from the limb stent graft was also present.

• Brand Name: AFX
• Common Device Name: LIMB 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: 16502619
• Report Number: 2031527-2023-00041
• Device Sequence Number: 15017497
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)211011
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/23/2023

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: 10/11/2021
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1996481-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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-0009-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL, SN (B)(4); AFX2 BIFURCATED STENT GRAFT, SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male