MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-110/I20-30

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Use of Device Problem (1670); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

The patient was initially treated with the afx2 abdominal aortic aneurysm stent.Approximately three (3) years post initial implant the patient was found to have a possible type iiib endoleak after review of the patients follow-up ct scan.The physician has scheduled an angiogram as well as a secondary procedure for a future date to address the findings.

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 iiib endoleak of the bifurcated device and secondary endovascular procedure.The clinical assessment also determined that there was evidence to reasonably suggest a type iiia endoleak mid-aortic occurred that was not included in the event as reported; this endoleak was discovered during the review of the 33-month post-implant ct scan.The event is most likely user-related due to the off-label use of the infrarenal extension in the left common iliac artery (oversized stent in the left leg of the bifurcated device).A contributing factor to the type iiie endoleak was most likely the poor wall-to-wall apposition observed on 33-month post-implant ct scan.Procedure-related harms for this complaint could not be determined.The patient was reportedly doing well post secondary endovascular repair.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.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(4) 2014.Correction: (b)(4).

Event Description

Additional information received confirming that the physician elected to treat the patient by relining with an additional bifurcated afx2 and suprarenal afx devices on (b)(6) 2019.During the procedure, no endoleak was evident but it was noted that the bifurcated device had dropped into the aneurysm sac.The patient was reportedly doing well post re-intervention.In addition, clinical assessment confirmed that a type iiia (aortic) endoleak was present at the time of the reported event.Clinical also determined the off-label use of the infrarenal (proximal extension) afx device in the left common iliac artery (lcia) at the time of the initial implant.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8376416
• MDR Text Key: 137361156
• Report Number: 2031527-2019-00108
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)170224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2017
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 1355042-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR