MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Complete Blockage (1094); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm (aaa), and thromboembolism of distal aorta and iliac.Approximately 5 months post initial procedure, the patient presented with right leg pain and a computed tomographic angiogram (cta) revealed an occluded right limb.The physician successfully revascularized the limb and placed two ovation limb extensions to treat this event.The patient is reportedly stable and discharged home.
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.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 occlusion of the right iliac limb is confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the occlusion of the right iliac limb is user related due to the off label right common iliac diameter of 9.7mm.The diameter should be 10-23mm.The off-label condition of no abdominal aortic aneurysm (aaa) was also a contributing factor.The final patient status was reported to be stable pending discharge home.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11021224
• Report Number: 2031527-2020-00372
• Device Sequence Number: 3814142
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)221112
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 11/12/2022
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 2308064009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR