MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA INFRARENAL

Model Number	A28-28/C75 V
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2018- endologix was made aware by a physician during a one (1) month follow up on a patient for a reported migration (1cm) of the cuff, without type 1a endoleak.Patient current status is stable.Patient was not symptomatic and no re-intervention is scheduled.Initial implant date (b)(6) 2017.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following event: the infra renal cuff migration without type ia endoleak complaint is refuted rather, there is cuff caudal movement.The complaint is most likely procedure related, movement was observed at the conclusion of the implant procedure following angioplasty.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable and on surveillance.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).
Event or Problem Description
Additional information received confirming that re-intervention was completed; the physician elected to treat the patient by implanting a suprarenal afx device on (b)(6) 2018.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7397543
• Report Number: 2031527-2018-00226
• Device Sequence Number: 70207
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)200816
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 03/05/2018

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: Physician
• Device Expiration Date: 08/16/2020
• Device Model Number: A28-28/C75 V
• Device Catalogue Number: F00795-08
• Device Lot Number: 1729001006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/05/2018; 12/03/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 09/14/2018; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED DELIVERY SYSTEM, LOT 1707800025
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR