MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I20-30
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2020
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 being treated for an abdominal aortic aneurysm (aaa).The patient had a right common iliac artery (cia) aneurysm and a left intrarenal iliac artery aneurysm.After occlusion of both iia endoleaks, one non-endologix (gore) excluder leg was implanted from the left cia to the external iliac artery (eia), one non-endologix (gore) excluder leg was implanted from the right cia to the eia, and then the afx2 bifurcated stent graft was implanted with additional ballooning.It should be noted that this procedure is outside the indications of use (off label) due to implant with a non-endologix sent graft.Angiography identified an intraoperative type iiia between the afx2 and excluder at the right cia.Additional ballooning was performed; however, via angiography the endoleak remained and an intraoperative type iiib endoleak was found.An additional afx2 bifurcated stent graft was implanted within the first afx2 resolving the intraoperative endoleaks.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative type iiib endoleak of the right common iliac artery is confirmed.The event is most likely user related due to the off label nature of the case as there was no abdominal aortic aneurysm sac, the iliac artery diameters were off label (should be 10-23mm), and there was concomitant product use condition ¿ of non-endologix stents being placed in the bilateral iliac arteries prior to placement of the afx2 bifurcated stent graft.Procedure related harms for this event could not be determined.The final patient status was reported to be good post operatively.The device remains implanted; therefore, a device evaluation cannot be completed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.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.Corrections: h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10182732
• Report Number: 2031527-2020-00176
• Device Sequence Number: 14129810
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)210413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/26/2020

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: 04/13/2021
• Device Model Number: BEA25-70/I20-30
• Device Lot Number: 2240538010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: GORE EXCLUDER LEG (NON-ENDOLOGIX UNK 1ST DEVICE); GORE EXCLUDER LEG (NON-ENDOLOGIX UNK 2ND DEVICE); GORE EXCLUDER LEG (NON-ENDOLOGIX UNK 1ST DEVICE); GORE EXCLUDER LEG (NON-ENDOLOGIX UNK 2ND DEVICE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR