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	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant devices are: catalogue # enlw1616c82e, serial # (b)(4), ubd: 2014-02-13, upn: (b)(4).Catalogue # enlw1616c82e, serial # (b)(4), ubd: 2014-04-18, upn: (b)(4).Catalogue # etlw1616c93e, serial # (b)(4), ubd: 2014-06-05, upn: (b)(4).
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 physician wanted to do another follow up exam after a regular annual ultrasound.The patient was not sure of the exam/procedure that needed to be done but stated the physician mentioned something about gluing.The physician confirmed that an ultrasound revealed an irregularity in the blood flow but no endoleak was observed.The ultrasound showed that the aneurysm sac shrank from 53 mm in diameter to 41 mm in diameter.The cause of the event was unknown and the physician elected to schedule the patient for a future angiogram on an unknown date.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• 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: 6837487
• Report Number: 2953200-2017-01379
• Device Sequence Number: 13612466
• Product Code: MIH
• UDI-Device Identifier: 00613994762382
• UDI-Public: 00613994762382
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR