MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number	A25-25/C55
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
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 ia endoleak with growth in the neck (aneurysm enlargement) 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.
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.The investigation summary for this event will be recorded and documented under 2031527-2018-00971.With this new information, this reported is no longer needed and requesting to have this report 2031527-2018-00967 cancelled.
Additional Manufacturer Narrative
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.The investigation summary for this event will be recorded and documented under 2031527-2018-00971.With this new information, this reported is no longer needed and requesting to have this report 2031527-2018-00967 cancelled.

• Brand Name: AFX
• Common Device Name: INFRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8201182
• Report Number: 2031527-2018-00967
• Device Sequence Number: 1558228
• Product Code: MIH
• UDI-Device Identifier: 00818009010261
• UDI-Public: (01)00818009010261(17)170718
• 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
• 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: 07/18/2017
• Device Model Number: A25-25/C55
• Device Lot Number: 1267817-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-BIFURCATED STENT GRAFT:1342797-004; AFX-LIMB STENT GRAFT:1336194-014; AFX-LIMB STENT GRAFT:1350055-005
• Outcome Attributed to Adverse Event: Other