MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-120/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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 and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately one and a half (1.5) years post initial procedure, a type 1a endoleak and a type 2 endoleak (non- device failure) were identified.Reportedly, the physician was planning to perform an open repair however no further information was provided.The patient's neck anatomy was considered off- label.This event was previously reported under mdr # 2031527-2018-00937.Now, approximately three (3) years post initial procedure, the physician reported a small endoleak of an indeterminate origin.Patient is currently being monitored.
Additional Manufacturer Narrative
A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.Please remove this complaint from your complaint system.Corrections: h6: patient code: remove code 1924.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately one and a half (1.5) years post initial procedure, a type 1a endoleak and a type 2 endoleak (non- device failure) were identified.Reportedly, the physician was planning to perform an open repair however no further information was provided.The patient's neck anatomy was considered off- label.This event was previously reported under mdr # 2031527-2018-00937.Now, approximately three (3) years post initial procedure, the physician reported a small endoleak of an indeterminate origin.Patient is currently being monitored.Additional information: during the investigation and review of medical records, the reported small endoleak of an indeterminate origin was identified to be coming from a non- endologix (dacron graft) that was implanted during the open repair that occurred in 2018 (reported under mdr # 2031527-2018-00937).A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.Please remove this complaint from your complaint system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11263580
• Report Number: 2031527-2021-00038
• Device Sequence Number: 1167035
• Product Code: MIH
• UDI-Device Identifier: 00818009014719
• UDI-Public: (01)00818009014719(17)170707
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: BEA25-120/I16-40
• Device Lot Number: 1517845009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 03/22/2021
• 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 # 1605368008; INFRARENAL AORTIC EXTENSION, LOT # 1605368008
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR