MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I16-40

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Misconnection (1399); Material Puncture/Hole (1504)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

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.Approximately six (6) years post initial procedure, a possible type ii, iiia, or iiib endoleak was detected by ct with aneurysm sac growth from 4cm to 6.3cm (greater than 5mm increase).The physician plans to reline with an ovation device and will continue to monitor the patient.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 ii endoleak and type iiia endoleak with mid-aortic component separation.The sac growth and type iiib endoleak complaints are refuted; rather, the aneurysm sac measured 64.7mm (1 month post initial implant) and 67.9mm (75month post initial implant), less than a 5mm growth.This complaint is most likely anatomy-related due to aortic remodeling.The clinical assessment also determined that there was evidence to reasonably suggest a type ib endoleak from the left common iliac artery.The procedure-related harms identified were the type ii endoleak from the inferior mesenteric artery and lumbar arteries.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: patient code - remove 1708.Device codes - remove 1068, 1354, 1504.Conclusion code - remove 11.

Event Description

Additional information received confirming that the physician elected to treat the patient by relining with ovation ix (main body, two iliac limbs, and two extenders) and an infrarenal afx devices on (b)(6) 2018.In addition, clinical assessment refuted the reported aneurysm enlargement and possible type iiib endoleak, and confirmed the presence of a type ib endoleak at the time of the reported event.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205378
• MDR Text Key: 131706959
• Report Number: 2031527-2018-00975
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Remedial Action: Recall
• 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: 01/31/2013
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1030190-009
• 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: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL AORTIC EXTENSION: (B)(4)
• Patient Outcome(s): Other; Required Intervention