MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Codes	Misconnection (1399); Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/11/2019
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 iiia endoleak with aneurysm enlargement (4.8cm to 5.5cm) were detected during routine follow-up ct.The physician plans to reline and will continue to monitor the patient.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 following reported events: a type iiia endoleak with complete component separation and aneurysm sac growth.There was unsubstantial evidence to indicate that a secondary endovascular procedure was performed.The clinical assessment also determined that there was evidence to reasonably suggest buckling of the bifurcated device (duraply) occurred that was not included in the event as reported; the buckling was discovered during the review of the 47-month post-implant ct scan.The event is most likely anatomy-related due to aortic remodeling over time (66°angle (aorta) between the bifurcated stent and suprarenal extension).The procedure-related harms for this event could not be determined, and rhe final patient status was reported as stable.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.Device iteration is afx with duraply.
Event or Problem Description
Additional information received per clinical assessment confirming that complete component separation and buckling of the bifurcated device were also present at the time of the reported event.Currently unable to confirm if re-intervention has been completed or scheduled for the patient.The complaint file will be reopened if additional information is received at a later time.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8493378
• Report Number: 2031527-2019-00166
• Device Sequence Number: 1315211
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)171117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 11/17/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251909-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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:1252469-012
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR