MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20 V

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Migration or Expulsion of Device (1395); Stretched (1601); Patient-Device Incompatibility (2682)

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

Event Date 01/17/2018

Event Type  Injury  

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

An afx bifurcated, vela suprarenal, and a vela infrarenal were implanted to treat an abdominal aortic aneurysm in 2014.The patient presented emergently approximately 3 years post-op with a rupture and a type iiia endoleak.The physician elected to performed an emergent repair on (b)(6) 2018 where two (2) gore thoracic stent grafts were implanted to successfully resolve the leak.The patient is reported to be stable and doing ok following the re-intervention.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; type iiia endoleak with component separation, aortic rupture, secondary endovascular procedure.Clinical evaluations was unable to find substantial evidence to support the reported patient in favorable condition.Additionally there was evidence to reasonably support the following observation; stent cage dilation of both cuffs and main body, movement of the suprarenal stent with telescoping into the infrarenal cuff, and sac growth.The most likely cause of the mid aortic loss of seal with implant separation was related to severe aortic remodeling.Likely contributors to this event were; the off label neck anatomy, the off label component selection, stent movement of the suprarenal cuff, and stent cage dilation of all three components.Procedure related harms and the final patient disposition could not be ascertained due to a lack of relevant medical records.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 (b)(6) 2015, field training was completed by (b)(6) 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.There have been no further reports of negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation 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.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7274105
• MDR Text Key: 100184241
• Report Number: 2031527-2018-00090
• 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: 01/17/2018

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: Physician
• Device Expiration Date: 02/25/2015
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1214306017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GORE DEVICE 1 -LOT: UNKNOWN; GORE DEVICE 2 -LOT: UNKNOWN; VELA-INFRARENAL-LOT: 1178436003; VELA-SUPRARENAL-LOT: 1214306017
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR