MAUDE Adverse Event Report: ENDOLOGIX AFX; PROXIMAL EXTENSION

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2021

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 unknown.Devices remain implanted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with an unknown stent system on an unknown date.The physician elected to implant an afx2 bifurcated stent graft and afx vela suprarenal proximal extension on (b)(6) 2021 to treat an unknown device failure.No additional information is currently available regarding this initial report.As the exact date of incident is unknown, the best estimate was used, which is the manufacturer awareness date to this event.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with an unknown stent system on an unknown date.The physician elected to implant an afx2 bifurcated stent graft and afx vela suprarenal proximal extension on (b)(6) 2021 to treat an unknown device failure.No additional information is currently available regarding this initial report.As the exact date of event is unknown, the best estimate was used, which is the awareness date to this event.Additional information received indicating that a type iiib endoleak of the proximal extension was present at the time of the reported event.In addition, the patient was reportedly also relined with gore (non-endologix) devices during the secondary endovascular procedure in october 2021.Clinical assessment additionally confirmed crown separation occurred that was not included in the event as reported.

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 could not be completed.The part number/lot number combination needed for device identification remains unknown.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 iiib endoleak (of the proximal extension) and secondary endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest crown separation occurred that was not included in the event as reported.This finding was discovered during an examination of an undated ct (computed tomography) scan.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.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 unknown.Corrections: b5 describe event or problem.D2 common device name (primary).D4 lot expiration date (primary); remove data.G3 awareness date.H6 medical device problem codes; remove 3190.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

• Brand Name: AFX
• Type of Device: PROXIMAL EXTENSION
• 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: 12845173
• MDR Text Key: 281028348
• Report Number: 2031527-2021-00469
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: 11/19/2021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 12/12/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention