MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/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	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 afx vela suprarenal were implanted to treat an abdominal aortic aneurysm (aaa).Approximately, 2 (two) years post initial procedure, a computerized tomography image identified a possible type iiia endoleak with device separation.Aneurysm enlargement was not identified.Reportedly, the patient is doing well and re-intervention is pending.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows a type iiia endoleak with complete component separation.This is consistent with the reported adverse event/incident.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.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 post-secondary 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 afx2.Corrections: b2: outcomes attributed to adverse event - updated b5: describe event or problem - updated h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal were implanted to treat an abdominal aortic aneurysm (aaa).Approximately, 2 (two) years post initial procedure, a computerized tomography image identified a possible type iiia endoleak with device separation.Aneurysm enlargement was not identified.Reportedly, the patient is doing well and re-intervention is pending.Subsequent to the initial report, additional information was received reporting that successful re-intervention was performed with implant of an afx vela infrarenal.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10299755
• Report Number: 2031527-2020-00206
• Device Sequence Number: 689747
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)180828
• Combination Product (Y/N): N
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: BEA28-70/I20-30
• Device Lot Number: 1732658005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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: AFX VELA SUPRARENAL (LN 1742861004); AFX VELA SUPRARENAL (LN 1742861004)
• Outcome Attributed to Adverse Event: Other; Required Intervention