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

Model Number	ENBF3620C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pain (1994); Rupture (2208)
Date of Event	04/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: encf3636c49e sn (b)(4), expiration date: 2013-10-18, udi # (b)(4).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 were implanted in a patient for the endovascular treatment for an abdominal aortic aneurysm.It was reported that a patient presented with back pain and low blood pressure, but was in stable condition.The physician stated that it was not caused by the previous endurant stent graft but the aorta above the renal arteries had expanded and possibly ruptured, but was contained.The films were reviewed and the physician decided to implant an endurant aortic cuff above the renal artery but below the superior mesenteric artery.This was done successfully with an endurant 36x36x70 aortic cuff.An angiogram was then performed and there was contrast getting around the stent graft proximally because the graft wasn't long enough to reach the seal zone.The physician decided to cannulate the sma coming from the brachial artery.Another manufacturer¿s covered stent was advanced into the sma up to the level of the celiac artery.Another endurant 36x36x49 cuff was then implanted to the level of the other manufacturer¿s covered stent and the celiac artery.Both were deployed simultaneously and a snorkel was created.The endurant cuff was then ballooned using a reliant balloon.Another aortogram was performed.There was no contest getting around the stent grafts.There was also never an endoleak into the distal aorta.The physician cannot determine the cause of the event.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: 6575826
• Report Number: 2953200-2017-00799
• Device Sequence Number: 994609
• Product Code: MIH
• UDI-Device Identifier: 00613994762351
• UDI-Public: 00613994762351
• 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,Followup
• Report Date (Section B): 04/22/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2013
• Device Model Number: ENBF3620C166E
• Device Catalogue Number: ENBF3620C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2017
• Supplement Date Received by Manufacturer: 04/22/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 68 YR