MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984); Thrombosis (2100)
Date of Event	02/29/2020
Type of Reportable Event	Death
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 initially implanted with a bifurcated stent graft to treat an occlusive disease in the distal aorta and thrombus lining the aorta from the bifurcation to the mid aorta.This case is outside the indications of use (off -label) due the device being used to treatment not approved per the ifu.It was also reported that physician had to perform a cut down during the initial procedure due to embolization.Approximately 16 days post initial procedure, the patient was present in the emergency room (er) due to an occluded aorta.It was reported that the patient was not taking the antiplatelet therapy and thrombosed the graft.The physician elected to treat the patient with a manual thrombectomy and implant two (2) non- endologix (gore) limb extensions to re-line the aorta.The re-intervention was successful however the patient was still in poor health.The patient expired on the following day.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images but the request for medical records was denied and no response was received for the request of medical images.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: result code ¿ remove 3233.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9914406
• Report Number: 2031527-2020-00123
• Device Sequence Number: 2764220
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)180721
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2020
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 1723092-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 62 YR