MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	11/22/2019
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 afx with duraply.".
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately, 3 years post initial procedure patient presented with a type iiia endoleak and was treated with an aortic extension.This event was reported under mfr# 2031527-2018-0079.Now, approximately four (4) years post initial procedure, the patient presented with an endoleak (of indeterminate origin) and as of date, there have been no additional patient sequelae 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 indeterminate endoleak was determined to be a type iiia endoleak of the right common iliac artery.Also a rupture and sac growth of approximately 23mm were identified.This event is most likely user related due to the infrarenal proximal extension being implanted into the right common iliac artery (off- label) and the diameter of the right common iliac artery is 35mm (should be 10-23mm).Procedure related harms for this event could not be determined.The final patient status was not reported.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".Corrections: h6: remove result code 3221.H6: remove conclusion code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately, 3 years post initial patient presented with a type iiia endoleak and was treated with an aortic extension.This event was reported under mfr#: 2031527-2018-0079.Now, approximately four (4) years post initial procedure, the patient presented with an endoleak (of indeterminate origin) and as of date, there have been no additional patient sequelae reported.Additional information: during the investigation, the reported indeterminate endoleak was identified to be a type iiia endoleak of the right common iliac artery.Rupture and sac growth of approximately 23mm were also identified.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9508918
• Report Number: 2031527-2019-00619
• Device Sequence Number: 16818071
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992(17)180422
• 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: 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): 11/22/2019

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: 04/22/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1331260-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/22/2019
• Supplement Report FDA Received Date: 07/13/2020
• 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: INFRARENAL AORTIC EXTENSION, LOT#1264693-007; INFRARENAL AORTIC EXTENSION, LOT#1267818008; VELA INFRARENAL, LOT#1461843016; VELA SUPRARENAL, LOT#1252485044
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR