MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-100/I20-40

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 12/01/2016

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

It was reported the patient had an initial implant on (b)(6) 2013 with a bifurcated stent and suprarenal aortic extension.On (b)(6) 2015, the patient had a type 3b endoleak and the physician elected to reline with an additional bifurcated stent.On (b)(6) 2016 a follow up computed tomography (ct) showed a potential type 3a or type 3b endoleak.A subsequent endovascular procedure has not been scheduled at this time.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 the reported type 3b endoleak of the proximal extension, a persistent type 3b endoleak of the main body and a type 3a endoleak.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, untreated endoleak type iiib of the cuff, and poor stent to stent apposition.The review of manufacturing lot confirmed all devices met specifications prior to release.The event devices have not been returned 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 of the reported event at this time.To date there has been no additional information on the current patient status.

• 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: 6216907
• MDR Text Key: 63687769
• Report Number: 2031527-2016-00603
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)180602
• 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: 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: 06/02/2018
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1346832-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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); BIFURCATED- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR