MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I13-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately four (4) years post initial procedure, a type iiib endoleak was detected by ct during routine follow-up.The physician will continue to monitor the patient who is reportedly in good condition.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of a type iiib of the bifurcated device.The reported minimal overlap of the afx bifurcated and proximal extension devices is refuted and rather, there is a confirmed 40mm of overlap observed.The event is most likely user-related due to the oversized proximal extension (outside the treatment range) in the bifurcated device.Procedure-related harms for this event could not be determined.The final patient status was reported to be monitored until further treatment.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.
Event or Problem Description
Additional information received per clinical assessment confirming that the patient's proximal extension device was oversized at initial implant.In addition, clinical refuted the reported minimal overlap between the bifurcated and proximal extension devices and rather, sufficient overlap was observed.The physician continues to monitor the patient and there is currently no plan to re-intervene.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8429815
• Report Number: 2031527-2019-00127
• Device Sequence Number: 10812607
• Product Code: MIH
• UDI-Device Identifier: 00818009010179
• UDI-Public: (01)00818009010179(17)170916
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 09/16/2017
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1279170-015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA INFRARENAL:1252523-029; AFX-VELA INFRARENAL:1252523-029
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR