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

Model Number A28-28/C95-O20V

Device Problems Hole In Material (1293); Leak/Splash (1354); Migration or Expulsion of Device (1395); Off-Label Use (1494); Stretched (1601); Patient-Device Incompatibility (2682)

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

Event Date 11/29/2017

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

Patient initially implanted with an afx bifurcated and vela suprarenal device.Recently, the patient presented with an endoleak type iiib.Patient underwent a reline on (b)(6) 2017 with ovation inside the afx grafts.Patient was reported as being fine post procedure and was discharged two days post procedure.

Event Description

Ct: (b)(6) 2015.

Event Description

Ct: (b)(6) 2015.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type iiib, and secondary endovascular procedure.Additionally there was evidence to reasonably support the following observations; egg shaped dilated appearance of the suprarenal cuff, and migration of the suprarenal cuff.The most likely cause of the stent migration was the off label neck anatomy.The most likely cause of the compromised stent graft integrity, whether it was the cuff or the main body stent, was the migration and/or remodeling of either component; he cuff is more suspect, given its appearance on the still photo.Procedure-related harms included exacerbation of preexisting medical conditions: urinary dysfunction and tachyarrhythmias.The patient was discharged home on the third post-operative day on anticoagulation.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.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%.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 3b endoleak events reported for afx devices has been reduced to <0.2%.A review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

Event Description

Ct: (b)(6) 2015.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type iiib, and secondary endovascular procedure.Additionally there was evidence to reasonably support the following observations; egg shaped dilated appearance of the suprarenal cuff, and migration of the suprarenal cuff.The most likely cause of the stent migration was the off label neck anatomy.The most likely cause of the compromised stent graft integrity, whether it was the cuff or the main body stent, was the migration and/or remodeling of either component; he cuff is more suspect, given its appearance on the still photo.Procedure-related harms included exacerbation of preexisting medical conditions: urinary dysfunction and tachyarrhythmias.The patient was discharged home on the third post-operative day on anticoagulation.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.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%.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 3b endoleak events reported for afx devices has been reduced to <0.2%.A review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.Correction: d2 & d4; updated device info h6 patient code: remove 1708.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7133988
• MDR Text Key: 95367855
• Report Number: 2031527-2017-00688
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012418
• UDI-Public: (01)00818009012418(17)170922
• 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,Followup
• Report Date: 11/29/2017

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: 09/22/2017
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1264514022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 11/29/2017; 02/27/2018
• Supplement Dates FDA Received: 03/05/2018; 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-VELA SUPRARENAL-LOT: 1264514-022; AFX-VELA SUPRARENAL-LOT: 1264514-022
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR