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	09/05/2017
Type of Reportable Event	Serious Injury
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 emergently.The patient had a proximal type i endoleak and the ruptured aorta.Review of the films revealed that the endurant bifurcated stent graft was intentionally implanted low in the aortic neck to salvage a large accessory renal artery.The endograft remained just below the level of the accessory renal with no migration; however the aortic neck had continued disease progression resulting in aortic neck dilatation.There was 2-3cms above the accessory renal to the level of the primary renal arteries.The physician gained guide wire access to the accessory renal and coil embolized the accessory renal artery so there would be no back bleeding.Then two endurant aortic cuffs 28x28x49 were implanted into the previous stent graft and extended above the bifurcated up to the level of the primary renal arteries.The endurant aortic cuffs were then ballooned using a reliant balloon.An aortagram was then performed and the proximal type i endoleak was resolved.Per the physician, the cause of the type i endoleak and ruptured aneurysm were related to the patient¿s anatomy; continued disease progression with aortic neck dilata tion.No additional clinical sequelae were reported and the patient is fine.

• 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: 6899940
• Report Number: 2953200-2017-01510
• Device Sequence Number: 1324331
• Product Code: MIH
• UDI-Device Identifier: 00613994762498
• UDI-Public: 00613994762498
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/05/2017

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: 08/22/2013
• Device Model Number: ENBF2816C145E
• Device Catalogue Number: ENBF2816C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/28/2017
• 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: 73 YR