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

Model Number	ETEW2424C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a 5.2 cm in diameter abdominal aortic aneurysm.It was reported that the final angiogram revealed a type 1b endoleak from the endurant ii-limb contra 16x20x124 stent graft that was implanted into the left common iliac artery.Implanted a 24x24x82 limb extension and the type ib endoleak improved, however the endoleak persisted.The physician determined that there was also a type ia endoleak.The physician modeled the proximal aortic neck with a balloon again but the proximal type ia endoleak was still present.It was reported that the bifurcated stent graft was implanted 1 cm (below the renal artery or lower than intended) therefore there was room to implant a endurant 28x28x49 aortic cuff.The type ia endoleak was significantly improved but there was still a persistent late small type ia endoleak.The physician modeled the endurant 16x24x124 ipsi-lateral extension limb on the right side with a balloon.There were still endoleaks present however, the physician decided that it was best for the patient do nothing further and follow up with a ct scan in approximately one month.Per the physician, the mostly causes of the events were related to the patient¿s anatomy; tortuosity of the aortic neck and iliac arteries.No additional clinical sequelae were reported and the patient will be monitored by the physician.On october 12, 2017 additional information was received for this case: it was noted that the bifurcated stent graft was implanted 1 cm below the left renal artery therefore there was room to implant an endurant 28x28x49 aortic cuff¿.Before the case began, the physician did not feel it was necessary to land the stent graft exactly at the left renal because the proximal neck was long about 30 mm.The exact date for the follow-up ct was not set as of (b)(6) 2017.
Additional Manufacturer Narrative
Films review summary: the cause of the distal type i and proximal type i endoleaks could not be determined from the pre-implant films provided.Images during implant were not available, and the films during the reported events could not be assessed.The proximal neck was moderately angulated, conical-shaped, with thrombus which may have contributed to the type ia endoleak.It is unclear if implanting 1cm below the renals may have led to the endoleak, since the neck was long (4cm).The distal 3.5cm¿s of the left common iliac artery was aneurysmal (16 ¿ 18mm diameter), and the iliacs were extensively calcified, which may have contributed to the reported distal type i seen within the lcia after implant.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,gw
• MDR Report Key: 6982847
• Report Number: 2953200-2017-01644
• Device Sequence Number: 10892362
• Product Code: MIH
• UDI-Device Identifier: 00613994991409
• UDI-Public: 00613994991409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2019
• Device Model Number: ETEW2424C82E
• Device Catalogue Number: ETEW2424C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1