MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA22-40/I13-40

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombosis (2100); Thrombus (2101)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.Device remains implanted.

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).Approximately six (6) months post initial procedure, the patient presented emergently with a cold leg and was identified with an acutely thrombosed graft.The physician implanted a vela suprarenal stent graft extension to resolve this event.Reportedly the patient is doing well.

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.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 an urgent presentation, occlusion of the aortic stent graft, and secondary endovascular procedure event / incident being confirmed.This is consistent with the reported adverse event / incident.The most likely causation for the reported complete occlusion below the renal arteries is likely anatomy related due to the pre-existing condition of aiod (aorto-iliac occlusive disease).The final patient status was reported as doing well.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: g1, 2: contact office- name has been updated.G4: date of received by manufacturer.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11042111
• MDR Text Key: 222618570
• Report Number: 2031527-2020-00376
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)230121
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 2325737008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR