MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/05/2019
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 afx2".
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 2.5 years post initial procedure, a computerized tomography (ct) revealed a possible type 3 endoleak of indeterminate origin.As to date, no intervention has been scheduled and the patient is being monitored.
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, clinical was able to find substantial evidence to refute the reported event of the indeterminate type 3 endoleak, rather it is identified as a type 3a (aortic) endoleak with the loss of overlap.The event is most likely anatomy related due to the aortic remodeling observed on the event computed tomography angiogram (cta) compared to the implant computed tomography angiogram (cta).As such, procedure related harms for this event could not be determined.The final patient status was reported as being stable post secondary procedure.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 afx2 with duraply.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G1,2: contact office- name has been updated.H6: device code: remove code 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 2.5 years post initial procedure, a computerized tomography (ct) revealed a possible type 3 endoleak of indeterminate origin.As to date, no intervention has been scheduled and the patient is being monitored.Additional information: the physician completed a successful reintervention and treated the patient with a vela suprarenal stent graft extension.The endoleak was resolved and patient was reportedly stable post reintervention.The indeterminate type 3 endoleak is refuted, rather it is a type 3a (aortic) endoleak with the loss of overlap.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8947003
• Report Number: 2031527-2019-00394
• Device Sequence Number: 2458775
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)170825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 08/25/2017
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1580601005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 06/11/2020
• 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: VELA SUPRARENAL, LOT#1612783026
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR