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

Model Number	ETLW1620C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 5 cm in diameter abdominal aortic aneurysm.It was reported that the final angiogram revealed a possible proximal type i endoleak and distal type i endoleak.The physician modelled the stent grafts with a reliant balloon and aggressively ballooned the proximal landing zone again.However due to the amount of contrast another angiogram to determine if the proximal type i endoleak was resolved was not performed.The c-arm was placed in a caudal position and the left sheath was injected showing at distal type i endoleak, the endurant 16x20x93 did not have enough purchase into the vessel.The physician elected to implant an endurant 20x20x82 limb extending down just proximal to the left hypogastric.The endurant stent grafts were modelled again with the reliant balloon, and the distal type i endoleak was resolved.The physician stated that the causes of the endoleaks were related to the patient¿s anatomy, proximal aortic neck angulation and the distal type i endoleak was due to not enough purchase into the vessel.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6363211
• Report Number: 2953200-2017-00291
• Device Sequence Number: 38337
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• 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
• 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): 02/06/2017

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: 01/27/2018
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: Required Intervention
• Patient Age: 86 YR