MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATION

Model Number	BEA25-70/160-30
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
During the initial implant of the afx devices it was observed the implanted stent dimensions did not match the dimensions on the label of the device.The procedure was completed and it was reported the patient had an unknown endoleak remaining at the end of the procedure.The unknown endoleak is addressed on an additional report to the fda.This report is for the potential mislabeling of the event device.There have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
The likely cause of the labeling issue could not be determined due to the lack of relevant imaging (ct scans or marker catheter angiography).Intravascular length measurements without the aid of a marker catheter can be inaccurate, not taking into account angulation of a three dimensional object visualized in two-dimensions.Based on the available information clinical was unable to determine the presence of procedure-related, anatomy-related and/or user-related issues.Additionally clinical was not able to determine off label or cautionary product use conditions.Devices remain implanted in the patient and were not returned for further investigation.The review of the manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX2
• Common Device Name: BIFURCATION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6840501
• Report Number: 2031527-2017-00445
• Device Sequence Number: 10940699
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)171116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2017
• Device Model Number: BEA25-70/160-30
• Device Lot Number: 1615578-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR