MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Leak/Splash (1354); Migration or Expulsion of Device (1395); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pseudoaneurysm (2605)

Event Date 01/05/2017

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.Devices remain implanted in the patient.

Event Description

It was reported the patient had an initial procedure with a bifurcated stent and a suprarenal aortic extension.A follow up showed the patient had a type 3a endoleak and a stent migration.On (b)(6) 2017 the physician elected to reline with ovation devices to seal the endoleak.The patient is reported to be in stable condition.

Manufacturer Narrative

(b)(4).The most likely cause for the stent migration was device related due to the dilated aortic cuff (compromised stent graft integrity).There were no detected user, anatomy, or procedure related issues that contributed to this event.There were no off label or cautionary conditions that might have contributed to this event.In addition, the original observation of a type iiia endoleak was refuted based upon clinical assessment.The device was not returned, therefore, sample evaluation was not completed.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The manufacturing records confirm that the lots met all requirements prior to release.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6474738
• MDR Text Key: 72174063
• Report Number: 2031527-2017-00154
• Device Sequence Number: 1
• Product Code: MIH
• 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: 03/10/2017

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: 08/31/2016
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1053309-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 03/10/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2013
• 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: SUPRARENAL AORTIC EXTENSION- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR