MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Thrombosis (2100)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 afx with duraply.
Event or Problem Description
The patient was initially implanted with afx bifurcated stent graft, and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years post initial procedure, the patient presented in stable condition with an expanding aaa sac identified via ultrasound.Angiography was performed identifying a possible type ib endoleak with the limb pulling up into the sac.The patient was treated with implant of a medtronic (non-endologix) iliac limb; however, a slight blush was still present.The patient will continue to be monitored.
Event or Problem Description
The patient was initially implanted with afx bifurcated stent graft, and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately 4.5 years post initial procedure, the patient presented in stable condition with an expanding aaa sac identified via ultrasound.Angiography was performed identifying a possible type ib endoleak with the limb pulling up into the sac.The patient was treated with implant of a medtronic (non-endologix) iliac limb; however, a slight blush was still present.The patient will continue to be monitored.Additional information: a type 2 endoleaks of the lumbar arteries (non-device related failure), a post-operative thrombosis and thrombectomy of the right common femoral artery immediately post index procedure occurred that was not included in the event as reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, the sac growth of 10mm, the type ib endoleak of the left common iliac artery and secondary endovascular procedure events are confirmed.The left limb movement is unconfirmed due to lack of relevant comparative imaging.During clinical assessment it was determined that there was evidence to reasonably suggest type ii endoleaks of the lumbar arteries (non - device related failure), a post-operative thrombosis and thrombectomy of the right common femoral artery immediately post index procedure had occurred.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records and imaging available for review.The final patient status was reported to be under surveillance.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10187191
• Report Number: 2031527-2020-00177
• Device Sequence Number: 2706635
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)180630
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265992009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL ((B)(4))
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR