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

Model Number 28-16-155BL - US SUREPASS_H

Device Problems Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354)

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

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Endologix was made aware of a patient with a bifurcated device collapse with an endoleak and aaa expansion from a follow up ct scan.The rep spoke to the patient's current physician, dr.(b)(6) at (b)(6) and noted that a secondary procedure will be needed.Patient is scheduled (tentatively) for a re-intervention to be performed on (b)(6).Patient had a prior endologix afx/strata graft implanted at (b)(6) hospital by dr (b)(6) some years back (2008).

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following finding of the main body stent collapse and sac growth.Clinical was able to find substantial evidence to support the following additional findings of type iiia endoleak with complete component separation.Due to the lack of relivent medical records, clinical was unable to confirm the reported event of urgent presentation, treated with non- endologix device and fem-fem bypass graft during the secondary endovascular procedure.Device, user, procedure or anatomy relatedness and procedure related harms of this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: VISIFLEX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7468775
• MDR Text Key: 106758055
• Report Number: 2031527-2018-00386
• Device Sequence Number: 1
• Product Code: MIH
• 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: 04/05/2018

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: Physician
• Device Expiration Date: 10/30/2009
• Device Model Number: 28-16-155BL - US SUREPASS_H
• Device Catalogue Number: F00193
• Device Lot Number: W06-1349R-009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUFF STENT GRAFT, LOT W07-2443-016; CUFF STENT GRAFT, LOT W07-2443-016
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR