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

Model Number	A28-28/C75V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
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.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with a bifurcated stent, a suprarenal aortic extension and two infrarenal aortic extensions.The infrarenal aortic extensions were implanted in the left and right iliac arteries as limb extensions.A follow up computed tomography (ct) in (b)(6) 2017, showed the patient had a type 1b endoleak from the right common iliac artery.The physician observed the limb extension was compressed causing blood flow to leak into the aneurysm sac, there was no aneurysm sac growth observed.The physician elected to implant an ovation limb extension to seal the endoleak.At the completion of the secondary intervention there was an endoleak remaining.The physician is going to refer the patient to another physician for additional treatment.To date a secondary intervention has not been reported to endologix.
Additional Manufacturer Narrative
Based upon the available information, the most likely root cause of the loss of seal in the distal area was off-label usage of an aortic extension used as a limb extension.The aortic extension was used due to off-label iliac artery anatomy.There were no user or procedure related issues.At the completion of the clinical assessment, there was evidence to support the following: unsuccessful endovascular repair of an iliac endoleak.The reported right common iliac artery endoleak type ib was refuted, rather the operative note indicated a significant left iliac artery endoleak.Associated clinical harms for this device failure included: an unknown endoleak and an unsuccessful endovascular procedure.The known final patient disposition was to be awaiting consultation to address the persistent endoleak.Device was not returned, therefore, sample evaluation was not completed.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.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6543097
• Report Number: 2031527-2017-00207
• Device Sequence Number: 616064
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)180715
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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: 07/15/2018
• Device Model Number: A28-28/C75V
• Device Lot Number: 1252145-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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 STENT- (B)(4); VELA INFRARENAL- (B)(4); VELA SUPRARENAL- (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR