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

Model Number	BEA25-110/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
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, a suprarenal stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure (exact date was not provided), sac growth was identified during a routine follow up.An intervention was completed.The physician elected to implant two (2) ovation ix extenders to treat this patient.No further information has been provided.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, a suprarenal stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure (exact date was not provided), sac growth was identified during a routine follow up.An intervention was completed.The physician elected to implant two (2) ovation ix extenders to treat this patient.No further information has been provided.As of the date of this report, there have been no additional patient sequelae reported.Additional information: during the investigation, clinical personnel identified a type ib endoleak of the left common iliac artery and the final patient status was discharged on the second post-operative day following a secondary endovascular repair.
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, the sac growth event is unconfirmed due to a lack of relevant medical imaging.During the investigation the clinical personnel identified a type ib endoleak of the left common iliac artery upon review of the 36-month post angiogram.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The final patient status was discharged on the second post-operative day following a secondary endovascular repair.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: remove result code 3233.H6: remove conclusion code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9342867
• Report Number: 2031527-2019-00522
• Device Sequence Number: 13999127
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)170701
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 07/01/2017
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1516630-032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA INFRARENAL, LOT 1516615003; VELA SUPRARENAL, LOT 1596253002; VELA INFRARENAL, LOT 1516615003; VELA SUPRARENAL, LOT 1596253002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR