MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-120/I16-40

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Material Puncture/Hole (1504); Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 02/07/2018

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 on (b)(6) 2014.Approximately four (4) years post initial procedure, aneurysm growth was detected by cta on (b)(6) 2018.The physician advised the patient at that time to treat the growth, but the patient refused treatment.The patient subsequently presented to a general surgeon at the hospital for a ruptured aneurysm on (b)(6) 2018 and expired.It was noted by the resident that assisted with the surgery that the graft had a hole, which is categorized as a type iiib endoleak.Endologix became aware of the reported event on (b)(6) 2018.

Event Description

Additional information received per clinical assessment confirming that the following product problems were also present at the time of the reported event: type iiib endoleak with lateral movement and stent migration of the cuff, stent buckling of the main body, and type ii and iiia endoleaks with stent cage dilation of the cuff and main body.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported events: sac growth, refusal of treatment, aneurysm rupture five months later, and subsequent death.The type iiib endoleak of both the cuff and main body was confirmed.This complaint is most likely device related; contributing factors include strata material and complete stent buckling of the main body, and lateral movement and stent migration of the cuff.The type iiib of the cuff was most likely user-related; this is due to the cuff being two sizes bigger than main body (34mm in 25mm) which is off label.Although there was a device malfunction, refusal of treatment by the patient five months prior to the rupture likely contributed to the patient's death.Additionally there was evidence to reasonably support the following observations: possible type ii endoleak, stent cage dilation of the cuff and main body, and a type iiia endoleak.Procedure related harms for this complaint could not be determined.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 3a endoleak.The root causes have been identified as; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.Off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type 3a endoleak events; 1.Sizing guidance and instructions were updated in the ifu and released on 17 jun 2015, 2.Field training was completed by 03 aug 2015.Since the corrective actions were implemented the type 3a events have been reduced significantly and are well within the acceptable range per our risk assessment.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%.Additional information: event; relevant tests/laboratory data; other relevant history; mfr site; report source; add device codes 1068, 1601, 2889; add method codes 3331, 4112 correction: date rec¿d by mfr; remove result code 3221 and add 4247; remove conclusion code 11 and add 22, 24, 4301.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7891492
• MDR Text Key: 120821252
• Report Number: 2031527-2018-00727
• 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
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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: 08/31/2016
• Device Model Number: BA25-120/I16-40
• Device Lot Number: 1111684-011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-VELA SUPRARENAL-1252452-003
• Patient Outcome(s): Death
• Patient Age: 74 YR