MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/19/2019
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 for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately one (1) month post initial procedure, a dissection of the left common iliac artery distal to the stent graft was detected by ct during routine follow-up.It was noted that the dissection was not present prior to the initial case and was likely a result of the aaa procedure.The physician also detected a large type ii endoleak.Physician plans to re-intervene to treat the dissection.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: left common iliac artery dissection distal to the stent placement and a type ii endoleak (lumbar).The event is most likely anatomy-related due to the highly tortuous left common iliac artery.The clinical assessment also determined that there was evidence to reasonably suggest a type ia endoleak occurred that was not included in the event as reported.The type ia endoleak was discovered during review of the 1-month post-implant ct scan, and is most likely related to the off-label neck (length was 7mm but should be greater than or equal to 15mm).In addition, the thick neck calcifications likely contributed to this event (cautionary product use condition).Procedure-related harms for this event could not be determined.The final patient status was reported to be in good condition.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.Device iteration is afx with duraply.Result code; remove 3221.Conclusion code; remove 11.
Event or Problem Description
Additional information received per clinical assessment confirming that a type ia endoleak was also present at the time of the reported event.The physician is not currently planning to re-intervene.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8501425
• Report Number: 2031527-2019-00182
• Device Sequence Number: 1884761
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)190709
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 12/18/2021
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 2021670-009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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-VELA SUPRARENAL:2021670-009; AFX2 BIFURCATED STENT GRAFT: LOT 1955108-001
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR