MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number I16-16/C55F SA

Device Problems Improper or Incorrect Procedure or Method (2017); Separation Problem (4043)

Patient Problem Aneurysm (1708)

Event Date 11/03/2023

Event Type  Injury  

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.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and four (4) afx limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) years after the initial procedure, the patient sought medical attention due to component separation and a type 3a endoleak.The patient underwent a re-intervention, during which the attending physician elected to implant three (3) ovation ix iliac limbs, an ovation ix extender, and an afx limb stent graft.The final patient status remains unknown.The final patient status was not made available to endologix.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's 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 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 afx, type iiia endoleak, component separation (main body and left iliac extension), and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an aneurysm enlargement of 14.6 mm in the right common iliac artery and 10.2mm in the left common iliac artery also occurred.The discovery was made during the examination of the 102-month post-implant computed tomography (ct) scan.The initial procedure is outside the instructions for use (ifu) due to concomitant device usage (non-endologix stent in the left internal iliac artery).The patient was also being treated for bilateral common iliac artery aneurysms.There was no abdominal aortic aneurysm, which would also be considered off-label.It is unclear if the off-label product usage contributed to the type iiia endoleak of the left common iliac artery.Device, user, procedure or anatomy relatedness of the complaint could not be determined.No procedure related harms were identified.The final patient status was reported as stable and discharged home on postoperative day six.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.Corrections: b5: describe event or problem ¿ updated.D10: concomitant medical products and therapy dates ¿ additional.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and four (4) afx limb stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) years after the initial procedure, the patient sought medical attention due to component separation and a type 3a endoleak.The patient underwent a re-intervention, during which the attending physician elected to implant three (3) ovation ix iliac limbs, an ovation ix extender, and an afx limb stent graft.The final patient status remains unknown.The final patient status was not made available to endologix.Additional information: the clinical assessment determined that there was evidence to reasonably suggest aneurysm enlargement of 14.6mm in the right common iliac artery and 10.2mm in the left common iliac artery occurred that was not included in the event as reported.The aneurysm enlargement was discovered during review of the 102-month post implant computed tomography (ct) scan.

• Brand Name: AFX
• Type of Device: 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: 18178884
• MDR Text Key: 328619290
• Report Number: 3011063223-2023-00038
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: I16-16/C55F SA
• Device Lot Number: 1039900-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0009-2019
• Patient Sequence Number: 1
• Treatment: AFX BIFURCATED STENT GRAFT 1055319-010; AFX LIMB STENT GRAFT 1040004R-003; AFX LIMB STENT GRAFT 1056305-014; AFX LIMB STENT GRAFT 1056305-015; GORE (NON ELGX) VIABAHN STENT; GORE (NON ELGX) VIABAHN STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male