MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I20-40
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/07/2019
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 an afx2 bifurcated stent graft and a non - endologix stent (gore excluder leg)to treat an iliac artery aneurysm.This case is outside the indications of use (off -label).A possible intraoperative type 3b was reported at the end of the procedure.Approximately four days later, it was reported that the endoleak had resolved itself as there is no endoleak present.The patient will be monitored.
Additional Manufacturer Narrative
Clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several requests were made for both; however, no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.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.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: d4: expiration date/udi - updated.G1,2: contact office- name has been updated.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: 9453386
• Report Number: 2031527-2019-00600
• Device Sequence Number: 3066735
• Product Code: MIH
• UDI-Device Identifier: 00818009014955
• UDI-Public: (01)00818009014955(17)191129
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 11/29/2020
• Device Model Number: BEA22-80/I20-40
• Device Lot Number: BEA22-80/I20-40
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 06/24/2020
• 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: ENDOLOGIX STENT (GORE EXCLUDER LEG).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR