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

Model Number	ETBF2516C145E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135)
Date of Event	05/08/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was attempted for use in a patient for the endovascular treatment of abdominal aortic aneurysm.It was reported that the endurant ii device was inserted through another manufactures sheath.The physician attempted to adjust the sheath backwards but was unable to move it.It was noted that another manufacturer's iliac stent was implanted two years prior was present in the right iliac artery.The physician then attempted to remove the endurant ii device, but could not.A reliant balloon was inserted and inflated to occlude the aorta so the sheath and endurant ii device could be removed.However, in the process of removal the vessel was avulsed just distal to the aortic bifurcation.It was further reported that the previously placed iliac stent had locked on to the sheath and forced the physician to remove the sheath and the endurant ii device together.It was also noted that the iliac stent had clung to the sheath and was removed as well.A surgical cut down and femoral-femoral by pass was performed to fix the vessel avulsion.It was then reported that care was withdrawn and the patient died three days post-operatively.The patient reportedly had poor respiratory status pre-operatively.Per the physician, it was unknown whether the death was related to the device.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Evaluation summary: the event could not be confirmed since it took place in-vivo.The root cause of the event could not be conclusively determined; however, was likely due to the competitor sheath becoming stuck on the previously implanted bare metal stent.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 6710983
• Report Number: 2953200-2017-01132
• Device Sequence Number: 11128995
• Product Code: MIH
• UDI-Device Identifier: 00613994991263
• UDI-Public: 00613994991263
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 08/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: ETBF2516C145E
• Device Catalogue Number: ETBF2516C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: 78 YR