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

Model Number	A28-28/C75V
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Necrosis (1971); Occlusion (1984); Pain (1994); Thrombosis (2100)
Date of Event	06/21/2019
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.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 had an endovascular aneurysm sealing (evas) to treat an abdominal aortic aneurysm (aaa).Extensive mural thrombosis was present prior to the evas.This procedure is outside the indications of use (off- label).A bifurcated stent graft (main body) and infrarenal stent graft were implanted.An intraoperative type 1a was reported but was resolved by ballooning.The endoleak disappeared and the operation was completed.6.5 hours post implant, the patient complained of abdominal pain.The superior mesenteric artery (sma) was occluded by thrombosis.An emergency operation was performed, and the occlusion was removed.On (b)(6) 2019, one day post implant, the patient was confirmed to have bowel necrosis and a part of bowel was removed by a surgical operation.The patient is making a recovering and being monitored.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported intraoperative type ia endoleak, superior mesenteric artery occlusion, mesenteric ischemia and emergent surgical procedure are unable to be confirmed due to a lack of relevant medical records and imaging.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported to be recovery after an abdominal surgery to address the mesenteric ischemia.The reported shaggy aorta is of note, this could have contributed to the reported superior mesenteric occlusion and resultant sequalae.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply corrections: d4: udi # - updated.G1,2: contact office/name - updated.H6: result code - remove 3233.H6: conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8833586
• Report Number: 2031527-2019-00340
• Device Sequence Number: 16190184
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17210502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2021
• Device Model Number: A28-28/C75V
• Device Lot Number: 1931084-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 05/07/2020
• 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, LOT 2232003-017
• Outcome Attributed to Adverse Event: Required Intervention