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

Model Number	ETLW1613C156E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5.2 cm abdominal aortic aneurysm.It was reported that a limb occlusion was discovered on ct imaging done.No intervention has been done and the event is ongoing.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
Evaluation summary: the exact cause of the limb occlusion could not be determined from the pre-implant films provided.Angiograms at implant, images at the occlusion event and post-implant were not available for review, and it is unclear which side was occluded.The blood flow dynamics and the stent graft in-vivo configuration could not be assessed from the films provided.A pre-implant film report revealed appreciable irregular-shaped thrombus within the neck, aaa, and iliac arteries.The proximal neck diameter measured 29mm below renal artery, and 26 ¿ 30mm (20 ¿ 24mm flow lumen) along the 23mm neck length.The distal aortic diameter was small (20mm).The right iliac artery was moderately tortuous and revealed a 180° curvature at the right hypogastric with areas of thrombus and calcification, and ranged in diameter from 12 ¿ 10mm.The 11mm diameter left iliac was essentially straight in a-p, and also contained thrombus and calcification.It is possible that the limb occlusion was anatomy related; the thrombus filled neck and aaa, small distal aorta, and calcified/thrombosed iliac arteries all may have contributed to the limb occlusion.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.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
• MDR Report Key: 6788340
• Report Number: 2953200-2017-01269
• Device Sequence Number: 132554
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 08/16/2017

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: 04/06/2019
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR