MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-100/I16-40

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Leak/Splash (1354); Stretched (1601); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)

Patient Problems Death (1802); Failure of Implant (1924)

Event Date 09/06/2018

Event Type  Death  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially treated with the afx abdominal aortic aneurysm stent on (b)(6) 2013.Approximately five (5) years post initial procedure, an endoleak type iiia and type iiib were detected through ct scan and angiogram.On (b)(6) 2018, the patient was relined with an ovation main body, 5 iliac limbs, and a cook 18 fr sheath was used.During the implantation, the right iliac artery was perforated with the 18 fr and 3 iliac limb were placed to seal the tear and the patient was reported as stable.The physician decided perform a cut down to explore the perforated iliac artery, at this time the patient became unstable and the physician converted to open repair to explant all devices.The physician clamped off all arteries but the patient's pressure continued to drop, finally the patient expired on the operating table.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following events: type iiib endoleak of the main body (with stent cage dilation of 70%), intraoperative perforation, open conversion, and intraoperative death.The reported type iiia endoleak is refuted as there was greater than a 6.0cm overlap observed on the event imaging.The clinical assessment also determined that there was evidence to reasonably suggest the following observations which were not included in the event as reported: significant stent buckling followed by a strut fracture of the main body with stent cage dilation, and placement of a non-afx stent within the left iliac portion of the main body stent at implant (adjunctive therapy for unknown reason).These findings were discovered during the review of the non-diagnostic images and the (b)(6) 2017 ct from 46 months post implant.Contributing factors most likely include: device related (strata material) type iiib endoleak, device related buckling and stent fracture of the main body with consideration of tortuous aorta and remodeling (patient anatomy), and procedure/user related right iliac perforation, intraoperative loss of blood, hypotension, conversion to open repair and patient death.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 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.

Event Description

Additional information received per clinical assessment refuting the reported type iiia endoleak.Rather, additional events of 70% stent cage dilation, stent buckling, and strut fracture of the main body were confirmed with placement of a non-afx stent within the left iliac portion of the main body stent at implant (adjunctive therapy).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7936141
• MDR Text Key: 122730111
• Report Number: 2031527-2018-00757
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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: 08/30/2015
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1047097-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX INFRARENAL -LOT: 1045109-009; AFX SUPRARENAL-LOT: 1026370-011
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR