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

Model Number	ETLW1624C82E
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft was implanted in a patient for the endovascular treatment of a 31 mm aorto iliac aneurysm.It was reported that the patient had an enlarged left common iliac artery and loss of seal in the left common iliac artery.During the reintervention procedure the left internal iliac artery was embolised and an endurant limb etlw1610c124e was extended into the external iliac artery.The event has been resolved through successful exclusion of the iliac aneurysm.The physician attributed the cause of the event to disease progression causing loss of seal.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information was received for this case: a talent bifurcate was previously implanted in this patient.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: 7424571
• Report Number: 2953200-2018-00538
• Device Sequence Number: 1592327
• Product Code: MIH
• UDI-Device Identifier: 00643169467477
• UDI-Public: 00643169467477
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 05/24/2018

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: 03/09/2019
• Device Model Number: ETLW1624C82E
• Device Catalogue Number: ETLW1624C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: 89 YR