MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208); Stenosis (2263); Blood Loss (2597)
Date of Event	10/19/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela surarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure a type 1a endoleak, sac growth (unknown diameter), and a narrowed proximal neck (classified as stenosis) were diagnosed during a routine follow-up.The physician elected to treat with a (off-label) palmaz stent and 3 cuffs to resolve the type 1a endoleak.Post re-intervention the patient was identified to have an additional endoleak at an undetermined origin.Patient expired one day post re-intervention.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type ia endoleak and indeterminate endoleak events are confirmed by medical records only.This is consistent with the reported adverse event/incident.The clinical evaluation also shows the sac growth and reported narrowing of the neck events are unconfirmed.The operative report dated (b)(6) 2020 shows the patient had degeneration of the thoraco-abdominal aorta and had a weakened aortic wall, contributing to the intraoperative rupture after the palmaz and endologix proximal extension stents were placed; therefore, the most likely causation for the reported death event is procedure-related due to the previously listed contributing factors.In addition, the patient left the operating room with a persistent but improved rupture, and was not an open repair candidate due to multiple comorbid conditions; these were also contributing factors to the reported death event.It is unclear what type of persistent endoleak was present intraoperatively after the palmaz stent was placed.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10861626
• Report Number: 2031527-2020-00340
• Device Sequence Number: 2559252
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)1801914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1252003012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/14/2021
• 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: AFX2 BIFURCATED STENT GRAFT - 1666139005; AFX2 BIFURCATED STENT GRAFT - 1666139005
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 84 YR