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

Model Number	ENBF3616C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/28/2012
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 emergent endovascular treatment of a 5.5 cm in diameter abdominal aortic aneurysm and a contained ruptured iliac artery aneurysm.It was reported that the patient returned for follow up and there is a punctate focus of air noted just above the aortoiliac bifurcation that is nonspecific in etiology.No evidence surrounding the periaortic inflammatory changes.The operative report indicates that the angiogram reveals that the previously reported punctate focus of air noted just above the aortoiliac bifurcation was resolved.Per the investigator, the punctate focus of air noted just above the aortoiliac bifurcation is most likely related to postsurgical in nature.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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: 6647633
• Report Number: 2953200-2017-00998
• Device Sequence Number: 1049116
• Product Code: MIH
• UDI-Device Identifier: 00613994762382
• UDI-Public: 00613994762382
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 11/07/2013
• Device Model Number: ENBF3616C145E
• Device Catalogue Number: ENBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: Other
• Patient Age: 75 YR
• Patient Weight: 105