MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-60/I16-40
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2019
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.Device remains implanted.
Event or Problem Description
The patient was implanted with two (2) afx2 bifurcated stent grafts, non- endologix (cook) proximal extension and non- endologix (cook) limb extensions to treat an abdominal aortic aneurysm (aaa).This procedure is outside the indications of use.The non- endologix (cook) proximal extension was implanted first.Then the first afx2 bifurcated stent graft was attempted to be implanted however due to the guide wire being behind the graft (incorrect location) the stent deployed prematurely in the aorta and was unable to be removed.The afx2 bifurcated stent graft was pushed/ crushed against the aorta walls and relined with another afx2 bifurcated stent graft.Then an additional non- endologix (cook) limbs were implanted.The procedure was prolonged an additional 2.5 to 3 hours.The procedure was completed with no additional events and the patient was reported as doing well.
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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.An attempt was made to obtain medical records and medical images but was denied as patient authorization is needed.As such, procedure related harms, event determination, related patient harms and patient disposition could not be assessed.However, as this procedure is outside the indications of use (off-label) due to concomitant use with non-endologix (cook) products outside the ifu, this may have cause or contributed to the event.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9569773
• Report Number: 2031527-2020-00007
• Device Sequence Number: 546750
• Product Code: MIH
• UDI-Device Identifier: 00818009014474
• UDI-Public: (01)00818009014474(17)180728
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 07/28/2020
• Device Model Number: BEA28-60/I16-40
• Device Lot Number: 1725263-016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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: AFX2 BIFURCATED STENT GRAFT, LOT 1725263014; COOK (NON- ENDOLOGIX) LIMB EXTENSIONS; COOK (NON- ENDOLOGIX) PROXIMAL EXTENSION; AFX2 BIFURCATED STENT GRAFT, LOT 1725263014; COOK (NON- ENDOLOGIX) LIMB EXTENSIONS; COOK (NON- ENDOLOGIX) PROXIMAL EXTENSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR