MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA22-90/I20-30

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

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

Event Date 12/03/2016

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.Devices remain implanted in the patient.

Event Description

Patient initially implanted with a bifurcated stent, a suprarenal aortic extension, and a limb extension on (b)(6) 2014.A follow up computed tomography (ct) showed aneurysm sac growth to 10 cm and a potential type 3 endoleak.The physician elected to reline the initial devices to seal the endoleak.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a type 3b endoleak with stent cage dilation.There was also evidence to reasonably support the following observations; suprarenal cuff stent dilation, and a type 1b endoleak of the left common iliac artery.The clinical evaluation additionally found evidence to suggest the following contributing factors to the reported event; component remodeling and poor stent to wall apposition.The review of manufacturing lot confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause at this time.There have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6216911
• MDR Text Key: 63687660
• Report Number: 2031527-2016-00605
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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: 04/30/2017
• Device Model Number: BA22-90/I20-30
• Device Lot Number: 1257013-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• 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
• Treatment: AORTO UNI-ILIAC [SUPRARENAL]- (B)(4); LIMB STENT- (B)(4)
• Patient Outcome(s): Required Intervention