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

Model Number	ETUF2314C102E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041)
Date of Event	05/26/2017
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 endurant aui stent graft system was implanted in a patient for the endovascular treatment a 5.4 cm in diameter abdominal aortic aneurysm.Patient has small calcified arteries.It was reported that after the deployment the endurant aui stent graft the device continued to move proximally multiple times.The physician pulled the device to the intended landing zone.A final angiogram was performed there was a full view of the renal artery and the markers were not covering the renal arteries.The patient¿s creatinine level went from 0.7 to 5.The ct revealed that the endurant aui was covering the renal artery.The physician attempted but was unable to access the renal artery.The patient was not producing urine days later.The patient was sent to dialysis.Per the primary physician, the causes of the events are due to the patient¿s anatomy, small calcified arteries.No additional clinical sequelae were reported and the patient will continue to be monitored by the physician.
Additional Manufacturer Narrative
Internal film review: review of pre-implant 3d recon report revealed that the patient had a 54 mm max diameter infrarenal abdominal aortic aneurysm.The right kidney was not visible in the images provided.The proximal aortic neck diameter ranged from 18-23 mm along a 33 mm length.The proximal aortic neck was not calcified but contained thrombus.The aortic neck was essentially straight.The distal aorta diameter measured ~ 13 mm.The right common iliac artery diameter ranged from ~ 10-14-12 mm along a 42 mm length.The left common iliac artery diameter ranged from ~ 10-9-9 mm along a 72 mm length.The right external iliac artery diameter measured ~ 8 mm.The left external iliac artery diameter measured ~ 7 mm.The iliac arteries were calcified and mildly angulated.Review of a single angio image during the implant procedure revealed that the patient has an endurant stent graft system implanted.The bifurcate was implanted with the top of the graft fabric covering the left renal artery.Although the ostium of the left renal artery appeared to be covered, contrast was still seen flowing into the left renal artery.The distal portion of the stent graft system was not visible in the image provided, so a complete assessment could not be performed.The bifurcate main body was essentially straight l-r.Per the calibrated catheter, the proximal bifurcate main body diameter measured ~ 18 mm l-r.No obvious stent graft issues were observed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6664055
• Report Number: 2953200-2017-01032
• Device Sequence Number: 72530
• Product Code: MIH
• UDI-Device Identifier: 00643169232556
• UDI-Public: 00643169232556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 07/07/2017

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: 09/06/2018
• Device Model Number: ETUF2314C102E
• Device Catalogue Number: ETUF2314C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/07/2017; 07/07/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/26/2017; 10/04/2017
• 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: 77 YR