MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I13-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft.Approximately five (5) years post initial implant the patient presented for a routine follow-up.It was found that the patient had a type ii endoleak as well as a type iiia endoleak.The physician plans on performing a re-intervention at a future undisclosed date.The current patient condition is unknown.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported events of a type iiia endoleak of the aortic components with a type ii endoleak of the internal mammary artery.The procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.This event is most likely anatomy-related due to the initial overlap of 50mm decreased in the 52-month ct scan to 25mm without evidence of aortic remodeling (root cause undetermined).The final patient status was not reported.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.(b)(4).
Event or Problem Description
Additional information received confirming that the physician elected to treat the patient by relining with an additional suprarenal and one (1) infrarenal afx devices on (b)(6) 2019.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8321449
• Report Number: 2031527-2019-00073
• Device Sequence Number: 2358153
• Product Code: MIH
• UDI-Device Identifier: 00818009010179
• UDI-Public: (01)00818009010179(17)170721
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 07/21/2021
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1264292-009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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 SUPRARENAL (LN (B)(4)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 80 YR