MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-110/I20-30

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 12/12/2022

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 afx2.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela infrarenal and an afx vela suprarenal proximal extension.Approximately four (4) years post initial procedure, the patient presented with a type ia endoleak, type ib endoleak and afx graft slippage into the aneurysm sac (classified as implant movement).The physician elected to treat the patient by implanting an alto abdominal aortic aneurysm stent system on (b)(6) 2022.The aneurysm was successfully sealed and the endoleaks resolved.Patient has been discharged home.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela infrarenal and an afx vela suprarenal proximal extension.Approximately four (4) years post initial procedure, the patient presented with a type ia endoleak, type ib endoleak and afx graft slippage into the aneurysm sac (classified as implant movement).The physician elected to treat the patient by implanting an alto abdominal aortic aneurysm stent system on (b)(6) 2022.The aneurysm was successfully sealed and the endoleaks resolved.Patient has been discharged home.Clarification: clinical assessment identified that the suprarenal extension migrated over 10mm.

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 migration (of 25mm) of the suprarenal extension, type ia endoleak, afx2 type ib endoleak (of the right common iliac artery) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.No procedure-related harms were identified.While the type ia endoleak is most likely related to the migration of the proximal extension, the device, user, procedure and anatomy relatedness of the type ib endoleak could not be determined.The cause of the migration is also indeterminate.The final patient status was reported to be discharged home on postoperative day one.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 afx2.Corrections: b5 describe event or problem g3 awareness date h6 health effect - clinical code; remove 1924 h6 medical device problem codes; remove 3026 h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 11.

• Brand Name: AFX2
• Type of Device: 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: 16098918
• MDR Text Key: 306681564
• Report Number: 2031527-2023-00004
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)190814
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 1967962-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX VELA INFRARENAL, SN (B)(4); AFX VELA SUPRARENAL, SN (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male