MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED

Model Number BA28-80/I20-40

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.

Event Description

An afx abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The initial procedure occurred 4 years ago.The patient returned for a routine follow-up where physician observed a type 3b endoleak and sac growth.The physician elected to re-intervene and re-line the afx device with a gore excluder.The procedure was successful.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the investigation, based on the information clinical evaluation was able to find substantial evidence to support the following reported events; endoleak type iiib of the main body, and aneurysm enlargement.Clinical assessment found evidence to refute the reported reline with a gore device, rather there was evidence to support an explant.Additionally there was evidence to reasonably support the following observations, endoleak type iiia with component separation, explant with open repair, and severe blood loss.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity was related to the strata graft material.The compromised fabric was noted during the explant procedure.Unable to be determined were any procedure, anatomy, or user-related issues as well as off label and cautionary product use conditions contributing to this event.Associated clinical harms for this device failure included: type iiib endoleak; sac enlargement; surgical conversion and abnormal blood loss from the explant procedure.The likely cause of the loss of seal was related to significant aortic angulation of 90 degrees noted on the 40 month follow up ct.Unable to be determined were any procedure or user related issues, or any off label or cautionary product use conditions that contributed to the event.Associated clinical harms for this device failure included: type iiia endoleak.The final patient disposition was discharged home on post operative day five in stable condition.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; upgraded graft material (i.E.Duraply) and 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.The type iiib 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%.Device was not returned, therefore, sample evaluation was not completed.The review of manufacturing lot 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.

Manufacturer Narrative

At the completion of the investigation, based on the information clinical evaluation was able to find substantial evidence to support the following reported events; endoleak type iiib of the main body, and aneurysm enlargement.Clinical assessment found evidence to refute the reported reline with a gore device, rather there was evidence to support an explant.Additionally there was evidence to reasonably support the following observations, endoleak type iiia with component separation, explant with open repair, and severe blood loss.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity was related to the strata graft material.The compromised fabric was noted during the explant procedure.Unable to be determined were any procedure, anatomy, or user-related issues as well as off label and cautionary product use conditions contributing to this event.Associated clinical harms for this device failure included: type iiib endoleak; sac enlargement; surgical conversion and abnormal blood loss from the explant procedure.The likely cause of the loss of seal was related to significant aortic angulation of 90 degrees noted on the 40 month follow up ct.Unable to be determined were any procedure or user related issues, or any off label or cautionary product use conditions that contributed to the event.Associated clinical harms for this device failure included: type iiia endoleak.The final patient disposition was discharged home on post operative day five in stable condition.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; upgraded graft material (i.E.Duraply) and 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 iiib 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%.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiia endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; 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 iiia endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, field training was completed by 08/03/2015.Since the corrective actions were implemented the type iiia events have been reduced significantly and are well within the acceptable range per our risk assessment.Device was not returned, therefore, sample evaluation was not completed.The review of manufacturing lot 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: (b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6606650
• MDR Text Key: 76492523
• Report Number: 2031527-2017-00275
• 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,Followup
• Report Date: 05/02/2017

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: Physician
• Device Expiration Date: 03/31/2014
• Device Model Number: BA28-80/I20-40
• Device Catalogue Number: BA28-80/I20-40
• Device Lot Number: 1101242-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 05/02/2017; 05/02/2017
• Supplement Dates FDA Received: 07/31/2017; 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR