MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2020
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 afx with duraply.
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 4.5 years post initial procedure, a type 3a endoleak with device separation was identified.Re-intervention completed successfully.The physician implanted an afx vela suprarenal sent graft to bridge the separated devices.The final patient status was reported as being stable.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains in the patient.A clinical evaluation of the adverse event / incident was completed.An examination of the still imaging received by endologix shows a type iiia endoleak of the aortic components with complete separation.This is consistent with the reported adverse event/incident.The most likely causation for the type iiia endoleak with complete separation is anatomy related due to the increase in the aortic angle from approximately 10 to 60 degrees (aortic remodeling).Procedure related harms, device, user or procedure relatedness of this event could not be determined with the absence of medical records and required and medical imaging available for review.During the investigation and with the information available, endologix found no evidence to suggest the device was used off-label.The final patient status was reported to be stable following a successful secondary endovascular procedure.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 afx with duraply.Corrections: b5: describe event or problem - updated.G4: awareness date - updated.H6: device code - removed 3190.H6: result code - removed code 3233.H6: conclusion code- removed 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 4.5 years post initial procedure, a type 3a endoleak with device separation was identified.Re-intervention completed successfully.The physician implanted an afx vela suprarenal sent graft to bridge the separated devices.The final patient status was reported as being stable.Updated: the patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx bifurcated stent graft, and afx vela suprarenal.Reportedly, there was insufficient overlap at the initial procedure; however, no endoleaks present.Approximately four and a half (4.5) years post initial procedure implant separation with a type iiia endoleak was identified at a routine follow-up.Re-intervention was completed successfully with implant of an afx vela suprarenal bridging the initial implant devices together.The final patient status was reported as being discharged one day post re-intervention and stable.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10526055
• Report Number: 2031527-2020-00252
• Device Sequence Number: 11067327
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)170729
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251902031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 09/12/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPRARENAL AORTIC EXTENSION 1352107026
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR