MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978); Unintended Movement (3026); Migration (4003)

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

Event Date 10/19/2018

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.Approximately three (3) years post initial procedure, an aneurysm enlargement (to 7.5cm) and type iiib endoleaks of the cuff and main body with minimal overlap between the two (2) devices were detected during routine follow-up cta.The physician will continue to monitor the patient who is reportedly doing well.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 reported events of the type iiib endoleak (and stent cage dilation) of the proximal extension device.The complaint is most likely device-related due to strata material, in combination with heavy calcifications at the neck and iliacs (cautionary).Procedure-related harms could not be determined, and the final patient status was reported to be doing well.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 july 2014.Device code - remove 1354.Conclusion code - remove 11.

Event Description

Additional information received confirming that the physician unsuccessfully attempted repair on (b)(6) 2019 due to the inability to gain access to the patient's right iliac artery.The physician attempted to treat with a perclose proglide (non-endologix) device which became stuck in the patient's vessel; patient was transitioned to a cut-down femoral artery procedure, and the device was successfully removed.The final angiogram showed no endoleak, but there was presence of proximal extension migration and minimal overlap between the bifurcated and proximal extension devices.The patient tolerated the procedure well.In addition, clinical assessment confirmed that stent cage dilation of the proximal extension was also present.This report is only for the suprarenal aortic (proximal) extension.Please refer to mfr.Report # 2031527-2018-00859 for report to the bifurcated stent graft.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8057559
• MDR Text Key: 126901438
• Report Number: 2031527-2018-00851
• 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: 10/19/2018

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: 08/31/2015
• Device Model Number: A34-34/C80-O20
• Device Lot Number: 1025847-046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT: 1047120-016
• Patient Outcome(s): Other
• Patient Age: 82 YR