MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/27/2018
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 with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, a type iiib endoleak of the bifurcated graft was detected by ct.The physician plans to reline with an ovation ix device and re-intervention is scheduled for (b)(6) 2019.There have been no additional patient sequelae reported.
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.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 3b and 1a endoleaks.The type 3b endoleak is most likely device related however the cause is unknown.The type 1a endoleak is most likely user related as a proximal stent extension should have been implanted at the index procedure.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: outcomes attributed to adverse events.Conclusion code: remove code 11.Device code: remove code 1354.
Event or Problem Description
Additional information: at the completion of the clinical assessment, clinical identified that both the 1a endoleak and the 3b endoleak were from the bifurcated stent graft and not the infrarenal aortic extension as previously reported under 2031527-2018-00967.The investigation summary for this event will be recorded and documented under this report.A secondary procedure was completed.The physician elected to implant two (2) a suprarenal stent graft extension to resolve this event.The patient was reported as doing fine post intervention.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8201488
• Report Number: 2031527-2018-00971
• Device Sequence Number: 158791
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180615
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 06/15/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1342797-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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-INFRARENAL AORTIC EXTENSION: 1267817-004; AFX-LIMB STENT GRAFT: 1336194-014; AFX-LIMB STENT GRAFT: 1350055-005
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR