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

Model Number	ETLW1628C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: etlw1616c82e, sn (b)(4), expiration date: 2018-03-29, udi #: (b)(4); etlw1620c156e, sn (b)(4), expiration date: 2018-09-13, udi #: (b)(4).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 implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.The proximal aortic neck was severely angulated.It was reported that during the implant of the endurant stent graft it was very difficult to see the origin of the right renal artery which was the lowest artery.During the procedure multiple injections attempting to visualize the right renal artery origin however were unable to see the origin but saw a double density which the physician thought was the right renal artery.The endurant stent graft was deployed with no problems.The contralateral gate was cannulated and a marker pigtail catheter confirmed the right renal was filing.The angiogram showed the renal filling.The physician then used another manufacturer¿s balloon to model the endurant stent graft.Upon the final angiogram the right renal was not filling and demonstrated that the right renal artery was covered/occluded.There were no endoleaks seen.The left arm was prepped and another manufacturer¿s 6 french sheath was inserted to the level of the renal arteries.The physician was able to get the other manufacturer¿s 6 french sheath behind the endurant stent graft to gain access to the right renal artery.The physician attempted multiple balloons, wires, and catheters to get past the endurant stent graft and into the renal artery.At one point the sheath was behind the graft and pulled back to try to balloon the track.At this point we were never able to advance the sheath back down or a stent.After 60 plus minutes of fluoroscopy the physician decided to stop and talk to the family about the graft covering the renal artery.Due to his pre-operative status an open bypass was not an option.The procedure was completed and will be monitored.It was reported that the patient experienced a stroke/cva post procedure and it was noted that it was related from the wire/catheter coming in from the left arm access to the right renal; however, the physician was unsure about the cause of the stroke.The physician stated that the causes of the right renal artery occlusion was due to the patient anatomy and unable to visualize the right renal artery.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6382109
• Report Number: 2953200-2017-00343
• Device Sequence Number: 13622139
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2018
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: Disability
• Patient Age: 72 YR