MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2018
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 for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately two (2) years post initial procedure, a type iiib endoleak with no aneurysm enlargement was detected per routine follow-up ct.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 following observations: the type iiib endoleak of the bifurcated device complaint is refuted and rather, there was noted contrast billowing (within acceptable range), stent cage buckling, and no aneurysm (sac) growth.The stent cage buckling was observed at one-month post initial implant.Procedure related harms and device, user, procedure, or anatomy relatedness of this complaint could not be determined.The final patient status was reported in good condition.
Event or Problem Description
Additional information received per clinical assessment confirming that there was no type iiib endoleak present at the time of the reported event; rather, clinical identified billowing and stent cage dilation of the bifurcated device.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8274203
• Report Number: 2031527-2019-00056
• Device Sequence Number: 13494679
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)170427
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: 04/27/2017
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1356499-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/30/2019
• 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:1472866-019; AFX-VELA SUPRARENAL:1472866-019
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR