MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-120/I16-40
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2021
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 a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a possible type 1a or 1b endoleak, and a type 3b endoleak were identified.Patient is currently being monitored while an intervention is being discussed.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, a possible type 1a or 1b endoleak, and a type 3b endoleak were identified.Patient is currently being monitored while an intervention is being discussed.Additional information: during the investigation, the reported possible type 1a or 1b endoleak was identified as a type 1a endoleak.Buckling of the distal bifurcated stent graft and probable migration of 33mm also occurred that was not originally reported.
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.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 the type 3b and1a endoleaks were confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 1a endoleak, buckling of the distal bifurcated stent graft and probable migration of 33mm occurred.The most likely causation for the type 3b endoleak and type 1a endoleak is the migration of the proximal extension.The final patient status remains unknown.The final patient status was not made available to endologix.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: h6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11368981
• Report Number: 2031527-2021-00057
• Device Sequence Number: 793021
• Product Code: MIH
• UDI-Device Identifier: 00818009014719
• UDI-Public: (01)00818009014719(17)171010
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 10/10/2017
• Device Model Number: BEA25-120/I16-40
• Device Lot Number: 1598797009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPRARENAL AORTIC EXTENSION, LOT # 1600033006
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR