MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Chest Pain (1776); Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 11/03/2016

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.

Event Description

It was reported the patient had an initial procedure on (b)(6) 2014 with a bifurcated stent and an infrarenal aortic extension.On (b)(6) 2016 a follow up and computed tomography (ct) showed a decrease in overlap between the main body and the proximal extension, lateral displacement of stent by about 5mm, the graft material stretched to diameter that appears to be about 4cm, and potential aneurysm sac growth.There was no endoleak observed.Patient has not been scheduled for a secondary procedure.Patient is in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the following reported events were confirmed; progressive loss of overlap, stretched fabric of the main body and sac growth.The reported event also indicated there was no presence of an endoleak, however, the clinical evaluation was able to confirm a type 3a endoleak.Additionally there was evidence to reasonably support the following observations; chest pain, shortness of breath, and coronary stent placement four weeks post implant.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; use of antiplatelet therapy, anticoagulation therapy, preexisting coronary artery disease, factor v leiden deficiency, and recent endovascular repair of an aortic aneurysm.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The 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 of the reported event at this time.

• 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: 6148972
• MDR Text Key: 61551553
• Report Number: 2031527-2016-00566
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)170730
• 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: 11/03/2016

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: 07/30/2017
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265980-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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: INFRARENAL AORTO UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR