MAUDE Adverse Event Report: ENDOLGOGIX AFX; VELA INFRARENAL

Model Number	F00795-13
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the investigation revealed a type ia endoleak, this complaint is most likely device related.No procedure related harms were detected.The final patient status was not reported.The clinical assessment determined that there was evidence to reasonable suggest a: stent cage dilation of the cuff (42%) and superior stent margin of the main body stent ( 26%); complete stent buckling of the main body stent, that were not included in the event as reported.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The manufacturing records confirm that the lots met all requirements prior to release.There were no ncrs included in these lots.Device was not returned, no evaluation completed.Devices remain implanted in the patient.The lot usage history shows one complaint (b)(4) involving lot#: 1342797 a type 3b endoleak.There were no other units from the affected lots that have been involved in any similar complaints at this time.Devices were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Reference: mdr 3 2031527-2018-00711 for type 3b endoleak.
Event or Problem Description
Additional information received during clinical assessment reported new events of a vela type 1a endoleak and stent cage dilation.There was a type ia endoleak, and a type iiib endoleak with complete stent buckling of the main body stent.This complaint is most likely device related.No procedure related harms were detected.Reference mdr # 2031527-2018-00711.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLGOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8057797
• Report Number: 2031527-2018-00853
• Device Sequence Number: 16463626
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)191212
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 12/12/2019
• Device Model Number: F00795-13
• Device Lot Number: 1625546018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR