MAUDE Adverse Event Report: ENDOLOGIX AFX

Model Number IS20-25/C55 SA

Device Problems Kinked (1339); Migration or Expulsion of Device (1395); Unintended Collision (1429); Retraction Problem (1536); Malposition of Device (2616); Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 05/19/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.The device involved in the event has been returned and is being evaluated.A follow-up report will be submitted when the evaluation is completed.

Event Description

It was reported that during aneurysm repair procedure, the bifurcated and suprarenal aortic extension were deployed without issue.A limb aortic extension was deployed in the patient's right common iliac artery and device seemed to deploy without issue.However, the nose cone caught the last stent segment and did not resheath in outer catheter completely.The physician re-advanced the nose cone by advancing inner core and again caught at proximal end of distal stent on limb extension.He then pulled the wire back to change the wire bias and did not work.Another less stiff wire was used and again in the nose cone got caught.The wire was then pulled completely back to eliminate bias altogether but the nose cone still would not track through the limb.The physician then attempted to advance the sheath over the device to capture above the limb, but the sheath would not track in to the limb extension due to the tortuosity.Attempted to re-advance the wire and it would not track through lumen which seemed to indicate inner lumen was badly kinked or broken.Final attempt before cut down was to pull everything out together.The delivery system with nose cone made it through the limb but significantly moved the limb distally and seemed to mangle the last stent.There was brisk flow through the limb but it appeared as though the distal limb was not sealed.The proximal aorta was sealed on a previous completion run.The physician repaired the patient's diseased common femoral artery which was unrelated to the device malfunction.After several unsuccessful attempts at re-cannulating limb form both ipsi and contra sides, surgeon opted to close case and order a computed tomography scan prior to patient discharge.

Manufacturer Narrative

Based upon the clinical assessment, the reported event is inconclusive.The afx limb extension was returned docked inside theafx introducer system.There was severe bulging/twisting marks on the introducer sheath likely from manipulations during the procedure while trying to remove the delivery system.There was no other anomalies detected.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.Based on the investigation findings, an exact root cause could not be identified based on the available information.However, the event description suggests that the nosecone caught the last stent segment during removal and likely contributed to the reported issues during the catheter removal.

• Brand Name: AFX
• Manufacturer (Section D): ENDOLOGIX; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5200659
• MDR Text Key: 30537548
• Report Number: 2031527-2015-00432
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1317721-010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/24/2015
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• 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
• Patient Age: 78 YR