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

Model Number BA28-70/I20-30

Device Problems Migration or Expulsion of Device (1395); Stretched (1601)

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

Event Date 12/09/2017

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.

Event Description

The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension and a limb stent.A follow up showed a loss of overlap with no endoleak.The physician proactively relined the initial implant with ovation devices to prevent additional stent movement.The final patient status was not initially reported.There have been no additional adverse events reported for this patient.

Event Description

Clinical was able to confirm the secondary repair on (b)(6) 2017.However, clinical refuted the cuff migration as reported, rather there was no migration observed.In addition, clinical noted sac growth; superior stent margin dilation of main body 36.6mm (30%); and left access complication (seroma), which required a surgical intervention.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.Clinical was able to confirm the secondary repair on (b)(6) 2017.However, clinical refuted the cuff migration as reported, rather there was no migration observed.In addition, clinical noted sac growth; superior stent margin dilation of main body 36.6mm (30%); and left access complication (seroma), which required a surgical intervention.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the loss of seal was the aortic remodeling, the loss of overlap which was exacerbated by the dilation of the main body stent (stretched 30%).The patient was discharged home in the stable condition on the third post-operative day.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7166469
• MDR Text Key: 96444654
• Report Number: 2031527-2018-00009
• 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: 12/09/2017

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: 10/31/2013
• Device Model Number: BA28-70/I20-30
• Device Catalogue Number: F00658
• Device Lot Number: 1090041-007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/09/2017
• Supplement Dates FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT- 1090041-007; LIMB STENT GRAFT, LOT 1040023-050; LIMB STENT GRAFT- 1040023-050; SUPRARENAL AORTIC EXTENSION, LOT 1025849-017
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR