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

Model Number	ETLW1613C156E
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
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 5.7cm abdominal aortic aneurysm and a 3.2cm left common iliac artery aneurysm.It was reported that the patient has had another manufacturers bifurcate stent graft implanted several years earlier.It was noted that during the initial implant of this bifurcate, it did not extend all the way to the left internal iliac artery.This uncovered portion of the left iliac became aneurysmal over time and it was necessary to coil the left internal iliac artery and extend down into the left external iliac artery with the endurant limb.It was reported that during deployment of the limb, the tip was advancing but the ro marker was not moving down in order to release the stent graft.Upon this discovery, the device was removed without being deployed.The procedure was completed with another limb stent graft without issue.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the exact cause of the stent graft deployment difficulties could not be determined from the pre-implant films provided.Films during implant were not available for review, and the reported event could not be assessed.Post-implant films were also not available.It is possible that implanting within the acutely angulated and potentially kinked pre-existing cook device may have led to the inability to deploy the limb.This may have also been related to a device issue.The device has been returned and is awaiting analysis, and the findings will be summarized in a separate report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: there was no gap visible on the device handle.A gap was observed between the stent graft and the stent graft stop.The stent graft appeared to have been pushed forward.A kink was observed on the graft cover and middle member proximal to the stent graft.The stent material was bunched on the proximal side.A number of kinks were observed along the graft cover.The stent graft was deployed with no issues noted.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: 7285227
• Report Number: 2953200-2018-00265
• Device Sequence Number: 11242165
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2018

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: 12/05/2019
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 06/19/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/27/2018; 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR