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

Model Number	ENBF2816C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/29/2017
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 an abdominal aortic aneurysm.It was reported that the patient presented with a ruptured aneurysm which had previously been treated with an endurant stent graft.The initial ct could not identify the endoleak, but the abdomen had blood throughout.The aneurysm is currently 7 cm in diameter.It was noted that the patient had been stable throughout.An angiogram was then performed and a type ib endoleak was identified in the ipsilateral limb of the endurant stent graft bifurcate.An iliac extension was placed, but was only able to gain an additional 5 mm of seal and the leak persisted.The right hypogastric artery was then coiled and another iliac extension was placed into the right external iliac artery and a leak could no longer be seen.This reportedly resolved the event.The physician stated that the case of the type ib endoleak was due to patient anatomy; specifically, the continued dilation of the iliac artery.The physician stated that the event was not related to the device.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 BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6509920
• Report Number: 2953200-2017-00647
• Device Sequence Number: 533129
• Product Code: MIH
• UDI-Device Identifier: 00613994762498
• UDI-Public: 00613994762498
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 08/28/2013
• Device Model Number: ENBF2816C145E
• Device Catalogue Number: ENBF2816C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 89 YR