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

Model Number	BEA25-110/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Separation Problem (4043)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2019
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 two (2) years post initial procedure (the exact date was not provided), a type 3b endoleak was reported.The patient is asymptomatic.An intervention was completed.The physician elected to implant two (2) infrarenal stent graft extensions to treat this reported event.As of the date of this report, there have been no additional patient sequelae reported.
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 two (2) years post initial procedure (the exact date was not provided), a type 3b endoleak was reported.The patient is asymptomatic.An intervention was completed.The physician elected to implant two (2) infrarenal stent graft extensions to treat this reported event.As of the date of this report, there have been no additional patient sequelae reported.Additional information: during the investigation, the reported type 3b endoleak was refuted, rather it was a type 3a endoleak with component separation.
Additional Manufacturer Narrative
The manufacturing record review did not reveal any issues or deviations that would explain the reported event.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 type 3b endoleak, rather it was a type 3a aortic with component separation as noted in the discharge summary.Procedure related harms, device, user, or anatomy relatedness of this event could not be determined based on medical records/ imaging available to review.The final patient status was reported as stable post the secondary endovascular 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.Corrections: h6: device code, remove 1504.H6: result code, remove 3233.H6 conclusion code, remove 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8933074
• Report Number: 2031527-2019-00381
• Device Sequence Number: 1948947
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)170722
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 07/22/2017
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1528890001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 05/30/2020
• 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 1629277012
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR