MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C80-O20V

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 11/25/2018

Event Type  Injury  

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 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.

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 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
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205377
• MDR Text Key: 131698152
• Report Number: 2031527-2018-00974
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)200928
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/29/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT: UNKNOWN LOT; AFX-VELA SUPRARENAL: UNKNOWN LOT
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR