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

Model Number	BEA25-110/I20-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2019
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 the investigation.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft to treat an abdominal aortic aneurysm.Approximately one (1) year post initial implant a review of the patients follow-up ct scan revealed a type iiib endoleak.The physician elected to perform a secondary procedure where the implantation of a non-endologix device was completed to resolve the issue.The patient is stated to be doing well post-secondary procedure.No further additional information or patient sequelae has been reported at this time.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of a type iiib endoleak of the distal bifurcated device.The device, user, procedure, or anatomy relatedness of this event could not be determined due to a lack of relevant imaging and records.Procedure-related harms for this event could not be determined.The final patient status was reported to be good post successful secondary endovascular procedure (reline) with a non-endologix stent.The clinical assessment also determined that there was evidence to reasonably suggest an endoleak type ii lumbar and a non-endologix left side limb stent occurred that was not included in the event as reported; these events were discovered during a review of the 8-month post ct scan.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.
Event or Problem Description
Additional information received per clinical assessment also confirming the presence of a type ii endoleak at the time of the reported event.In addition, clinical identified that a left side non-endologix stent was implanted at the time of the initial case.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8453489
• Report Number: 2031527-2019-00139
• Device Sequence Number: 16465890
• Product Code: MIH
• UDI-Device Identifier: 00818009014818
• UDI-Public: (01)00818009014818(17)180929
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: 09/29/2018
• Device Model Number: BEA25-110/I20-30
• Device Lot Number: 1745162-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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-0007-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR