MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent.Three (3) days post initial procedure, a type ia endoleak of the suprarenal afx device was detected by ct exam; the patient was asymptomatic.The physician elected to treat the patient by implanting an additional suprarenal afx device on (b)(6) 2018.No endoleak was observed per final angiography and the patient was reported in stable condition.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: type ia endoleak (3 days post initial procedure) and secondary endovascular procedure.This complaint is most likely user-related due to the off-label neck anatomy of the patient's 10mm neck length; the ifu requires a non-aneurysmal aortic neck length of greater than 15mm.The procedure related harms for this complaint could not be determined, and the final patient status was reported to be stable.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: device codes - remove 1068, 1354.Conclusion code - remove 11.
Event or Problem Description
Additional information received per clinical assessment confirming that the patient had an off-label neck anatomy at the time of the initial implant.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205377
• Report Number: 2031527-2018-00974
• Device Sequence Number: 1106973
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)200928
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 09/28/2020
• Device Model Number: A34-34/C80-O20V
• Device Lot Number: 1744717-019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/29/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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: AFX-BIFURCATED STENT GRAFT: UNKNOWN LOT; AFX-VELA SUPRARENAL: UNKNOWN LOT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR