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

Model Number	ETBF2313C124E
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	06/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was planned to be implanted in a patient for the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported that during the index procedure the physician attempted to introduce the bifurcated stent graft etbf2313c124e thought the left external iliac but was unsuccessful.It was reported that the physician then pre-dilated the left external iliac with a non mdt 8x40 pta balloon and it was thought that an iliac tear occurred at this point.The physician was still unable to advance the bifurcated stent graft delivery system through the external iliac.The physician removed the delivery system and placed a 14f sheath to achieve haemostasis in the arteriotomy.The physician then attempted to balloon the left external iliac with a 10mm pta balloon.Upon removing the contrast from the pta balloon, the anaesthesiologist stated that the blood pressure was dropping.The physician then advanced the 14f sheath into the distal aorta and then placed an endurant ii iliac extension stent graft etew1010c82e into the sheath.After positioning the sheath distal to the iliac tear, the physician deployed the stent graft.The physician stated that the blood pressure stabilized.It was reported the left iliac tear was successfully treated with the iliac extension and the physician converted to an open surgical repair to repair the aneurysm.The patient subsequently expired during recovery due to complications related to the aaa repair and poor tissue anatomy of the patient.Per the physician, the cause of the event was due to calcium in the left iliac causing the left iliac to tear.No additional clinical sequelae were reported.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 7645505
• Report Number: 2953200-2018-00906
• Device Sequence Number: 16557014
• Product Code: MIH
• UDI-Device Identifier: 00613994991164
• UDI-Public: 00613994991164
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2020
• Device Model Number: ETBF2313C124E
• Device Catalogue Number: ETBF2313C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 58