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

Model Number	ETUF3214C102E
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Malposition of Device (2616); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041)
Date of Event	01/08/2017
Type of Reportable Event	Serious Injury
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 aneurx stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.The patient presented emergently.An endurant stent graft was implanted during intervention.It was reported that aneurx stent graft had migrated distally into the aneurysm sac landing perpendicularly resulting in a proximal type i endoleak.The physician advanced a 32x14x102 endurant aui through the right limb of the previously implanted aneurx stent graft positioning the device just below the left renal artery.However, during the recapturing of the nose cone, the endurant aui device moved proximal covering the left renal artery.The physician cannulated the left renal artery, but then the wire came out during repositioning of another manufacturer¿s catheter.During the advancing of the catheter up through the right limb into the endurant aui device, the sheath impinged the distal area of the endurant aui device.The physician gained access via the left brachial artery, advancing a guidewire down through the aorta, through the endurant aui and snared the guide wire through the right groin.A reliant balloon was advanced into the distal part of the endurant aui and ballooned open.Another attempt to cannulate the left renal artery was unsuccessful.An angiogram revealed blood flow to both renal arteries.Therefore the physician aborted trying to cannulate the left renal artery and implanted the endurant distal limb of the aui.The physician also inserted an aptus guide at the top of the aui device.Five aptus endoanchors were implanted.Due to the tortuosity, manipulation of the guide, and torque build up, the guide was not as easy to manipulate as the physician wanted.Therefore, the first guide was removed and a second guide was used to implant an additional two aptus endoanchors.Then the reliant balloon was used to re-balloon the proximal area of the endurant aui and the overlap with the distal iliac limb.An angiogram was performed and it showed a proximal type i endoleak on the left.The physician decided to do no further intervention at this time.Two days post intervention procedure the physician stated that the patient¿s aaa was not palpated.A renal duplex was completed and the left renal artery was compromised.There was no intervention at this time to the left renal artery as the patient was producing urine.The physician will continue to monitor the patient.The physician stated that the cause of the event is related to the patient anatomy.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 AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6274659
• Report Number: 2953200-2017-00095
• Device Sequence Number: 763501
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• 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
• 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): 01/08/2017

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: 06/07/2018
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2017
• Supplement Date Received by Manufacturer: 01/08/2017
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: Required Intervention
• Patient Age: 87 YR