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

Model Number	ETUF3214C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/22/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii aui stent graft system was implanted in a patient for the endovascular treatment of a 73mm diameter abdominal aortic aneurysm.The proximal landing zone was 18mm in length and a diameter of 27mm with focal calcification on the right anterior aortic wall that was approximately 4mm distal to the lowest renal artery.The right proximal common iliac was chronically occlusive.The left common iliac diameter ranged from 12-14mm with moderate calcification.Access was heavily calcified.The endurant aui was implanted at the level of the lowest renal artery.It was reported that post implant angiogram revealed a type ia endoleak.Additional post implant dilatation was performed with a reliant balloon which did not resolve the endoleak.The physician then successfully implanted 8 endoanchors circumferential but primarily focused on the patients right anterior wall; however, the endoleak was not resolved.An additional 12 endoanchors were successfully implanted; however, the type ia endoleak was still persistent.Due to a reduction of the endoleak from the initial post implant arteriogram, the physician decided to end the procedure and monitor the situation with a follow up ct scan.However, it was reported that the patient received re-intervention two (2) days post index procedure for the persistent type ia endoleak.The endoleak was resolved with the addition of a proximal aortic cuff in conjunction with parallel covered stent bypass.Per the physician the endoleak was anatomy related (neck angle with focal calcification).It was reported that the patient expired after the secondary procedure.The physician stated that the cause of death was not device related nor related to the aneurysm.It was reported that, as per the physician, the patient health status at the time of procedure was the cause of death due to other co-morbidities.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Films review summary: the exact cause of the proximal type i endoleak could not be determined from the limited films provided.Ct¿s prior to and post-implant were not available therefore a complete assessment of the patient¿s anatomy could not be performed, and additional films during implant were not available.Several still angiograms during the implant were returned; the infrarenal neck appeared severely angulated ~90 deg in the a-p axis relative to the distal aorta.An endurant aui was seen having been implanted just below the renal arteries, and a proximal type i endoleak was observed.After implanting 15 ¿ 20 endoanchors primarily along the proximal right/anterior aortic wall at the aui outer curvature, the type ia endoleak was again observed.At the intervention the proximal type i endoleak appeared to have resolved following placement of an aortic cuff which was implanted ~30mm above the aui, covering the bilaterally s tented and chimney¿d renal arteries.It appears likely that the severely angulated proximal neck, in conjunction with the reported focal calcification on the right anterior aortic wall, all contributed to the endoleak.The cause of death could not be determined, but was assessed by the physician as due to other co-morbidities.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: 7028122
• Report Number: 2953200-2017-01765
• Device Sequence Number: 19295568
• Product Code: MIH
• UDI-Device Identifier: 00643169232617
• UDI-Public: 00643169232617
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/11/2017

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: 07/11/2019
• Device Model Number: ETUF3214C102E
• Device Catalogue Number: ETUF3214C102E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: 80 YR
• Patient Weight: 55