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

Model Number	ETUF2514C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the cause of the events could not be determined from the films provided.Pre-implant still images confirmed a moderately angulated proximal neck which was calcified, and the distal aorta and both iliac arteries were very small caliber and extensively calcified.Several short length video¿s after implanting the aui, limb extension, and 4 endoanchors confirmed contrast outside the stent graft filling the proximal sac, primarily from the right side/outer curvature of the aui from a possible proximal type i endoleak and/or type iv endoleak.The approximate same level of contrast was then observed after implanting additional endoanchors within the proximal aui.It is possible that the angulated and calcified proximal neck may have contributed to the possible type ia endoleak.A type iv endoleak due to fabric porosity may have also occurred.Retrograde injection distal to the left external iliac artery showed contrast outside and proximal to the occluded left common iliac artery and filling the aaa; the cause or source of the contrast/endoleak could not be determined.Images during ballooning were not observed in the films provided.However, it is possible that the source of the contrast may have been from a left common iliac artery dissection occurring during implant, possibly caused during ballooning the area near the calcified and very narrow distal aorta.Final images after the fem-fem bypass were not provided.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 aorto-uni-iliac stent graft system was implanted in the patient for the endovascular treatment of a 45 mm in diameter saccular abdominal aortic aneurysm.Aptus endoanchors were initially implanted as a prophylactic.There was proximal aortic neck calcification.The left and right iliac arteries were calcified.The access vessels were small and diseased.It was reported that during the index procedure a proximal type i endoleak was observed after implanting the endurant ii stent graft system and four aptus endoanchors.The physician elected to implant four additional aptus endoanchors in the infrarenal aortic neck and ballooned the area but the endoleak did not resolve.The physician then observed a spiral dissection in the left iliac artery with retrograde flow into the abdominal aortic aneurysm sac.The physician successfully completed the procedure with a femoral to femoral artery bypass and an iliac ligation.The proximal type i endoleak was still present at the end of the procedure.Per the physician the cause of the proximal type i endoleak was possibly due to an angulated proximal aortic neck.The physician stated that the dissection occurred due to dilation of the right common iliac artery, at the distal aspect of the aortic bifurcation, with a pta balloon prior to inserting the endurant ii delivery system.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: 6280640
• Report Number: 2953200-2017-00110
• Device Sequence Number: 13765046
• Product Code: MIH
• UDI-Device Identifier: 00643169232570
• UDI-Public: 00643169232570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/04/2017

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: 09/15/2018
• Device Model Number: ETUF2514C102E
• Device Catalogue Number: ETUF2514C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/26/2017
• 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: 78 YR
• Patient Weight: 44