MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ETTF3636C70E

Device Problems Difficult to Remove (1528); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 04/08/2014

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in a patient for a previous coarctation thoracic aorta repair.The endurant ii aortic extension was placed antegrade through a transapical incision transapical approach through the apex of the heart into the ascending aorta.The device was deployed and the delivery system was advanced forward to recapture the tip capture.The tip capture was caught on the proximal stents.The physician attempted to rotate and move proximal, but the tip capture did not release.The device was pulled back, but the proximal nose cone caught on the stent graft.The device was advanced and attempted to capture the tip capture, but caught on a stent.The backend wheel was rotated to open the tip capture mechanism, but did not open.The handle was disassembled to expose the inner mechanism to pull back on the tip capture mechanism.The sheath on the graft was moved forward to allow the graft to advance and the physician used a hemostat to pull back the tip capture mechanism.The sheath was then advanced forward and the deployment was removed.During the manipulation the stent graft was pushed forward into the transverse arch, contorting the distal end of the graft.An angiogram was performed to confirm position and another manufacturer¿s stent was placed in the innominate artery for flow into the transverse aorta.A second device 36x36x70 was placed proximal to the previous graft to attempt to cover the pseudo thoracic aneurysm.The second device was deployed covering the lad and the physician attempted to capture the tip capture mechanism but was unsuccessful because the proximal end of the device did not open, because it was constrained by the previous deployed stent graft.An ensnare was used to snare the nose cone.The nose cone was pulled down and the device was able to move forward.The tip capture mechanism back end wheel failed.The handle was disassembled to expose the inner mechanism and the physician was able to retract the tip capture.The physician was able to resheath the device and extract the delivery catheter.During the manipulation the device was pushed forward uncovering the lad, restoring flow.The delivery catheter was removed, but caught on the apex of the heart, but was removed with manipulation.A post angiogram was performed indicating flow to all three great vessels and through the stent graft.No clinical sequelae were reported.

Manufacturer Narrative

(b)(4).Conclusion: retrograde implantation of the stent graft into the ascending thoracic aorta and using endurant abdominal aortic aneurysm tube stent grafts in the thoracic aorta.

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3790110
• MDR Text Key: 4437470
• Report Number: 2953200-2014-00921
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2016
• Device Catalogue Number: ETTF3636C70E
• Device Lot Number: V04211543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Date Device Manufactured: 02/18/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00029 YR