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

Model Number A34-34/C100-O20 V

Device Problems Collapse (1099); Fracture (1260); Leak/Splash (1354); Torn Material (3024)

Patient Problem Failure of Implant (1924)

Event Date 12/18/2017

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

The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension and a limb stent.The patient came in for a routine follow up and computed tomography (ct) showed the patient had a type 3b endoleak of the proximal extension and a collapsed stent due to the angulation of the patient anatomy.The physician is monitoring the patient and a secondary procedure has not been scheduled.The patient is reported to be asymptomatic and in stable condition.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, clinical was unable to confirm if patient had an endoleak type iiib of the cuff with a stent graft collapse, patient reported to be doing well under surveillance otherwise.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, procedure related harms and the final patient disposition could not be determined due to a lack of any medical records or imaging.There have been no further reports of negative patient sequelae.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%.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

Event Description

Additional information was provided by the rep.On 01/16/2018.The patient was seen for a routine 1 year follow up.Physician was unable to confirm the ct showing the failure.A secondary procedure has not been completed, the physician has been monitoring the patient.The patient is reported to be asymptomatic and in stable condition.The type 3b endoleak is possibly of the proximal extension.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7198574
• MDR Text Key: 97473985
• Report Number: 2031527-2018-00040
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)190607
• 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: 12/18/2017

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: Health Professional
• Device Expiration Date: 06/07/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1484367-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT- 1356498-012; LIMB STENT GRAFT- 1252552-029; AFX2 BIFURCATED STENT GRAFT- (B)(4); LIMB STENT GRAFT- (B)(4)
• Patient Outcome(s): Other
• Patient Age: 66 YR