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

Model Number	ETBF3620C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a 6.0cm thoracic aortic aneurysm with a 1.5cm proximal aortic neck and a 3.0cm diameter aorta at the renal artery.There was mild vessel calcification.It was reported that during a patient follow up, a type iiib endoleak was observed on the angiogram and the fabric tear was noted to be just above the flow divider of the main body.The patient received treatment with an aui device implanted to reline the stent graft as the physician believed this to be the only way to resolve the endoleak and there was no endoleak present upon completion.As per the physician the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
An endurant stent graft system was implanted in a patient for the endovascular treatment of a 6.0cm abdominal aortic aneurysm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II 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: 7291568
• Report Number: 2953200-2018-00276
• Device Sequence Number: 11075355
• Product Code: MIH
• UDI-Device Identifier: 00613994991058
• UDI-Public: 00613994991058
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 08/15/2015
• Device Model Number: ETBF3620C145E
• Device Catalogue Number: ETBF3620C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 86 YR
• Patient Weight: 80