MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure (the exact date was not provide), a type 1a endoleak was identified.A secondary procedure was completed.The physician elected to implant a suprarenal stent graft extension to resolve this leak.The intervention was successful and the patient was reported as stable.
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 confirm the following events of a type 1a endoleak and a secondary procedure.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records and imaging available for review.The final patient status was discharged on the first post -operative day home stable following a successful 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 afx with duraply corrections: b1: has been updated g1,2: contact office- name has been updated h6: result code: remove code 3221 h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure (the exact date was not provide), a type 1a endoleak was identified.A secondary procedure was completed.The physician elected to implant a suprarenal stent graft extension to resolve this leak.The intervention was successful and the patient was reported as stable.Additional information: during the clinical assessment it was determined that a right renal artery stent (non-endologix) was also implanted during the secondary procedure to treat this event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8668831
• Report Number: 2031527-2019-00264
• Device Sequence Number: 19406340
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)181223
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2018
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1292995-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 04/28/2020
• 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 1252166007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR