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

Model Number	ENBF2516C145E
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Hemorrhage/Blood Loss/Bleeding (1888); Injury (2348)
Date of Event	07/06/2018
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm.It was reported that approximately 5 years post index procedure, the patient presented at follow up with a type ia endoleak.Intervention was completed with the placement of endoanchors and balloon angioplasty and the endoleak resolved.Per the physician the cause of the event was anatomy related due to the excess calcification present.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: 7717635
• Report Number: 2953200-2018-01100
• Device Sequence Number: 1120914
• Product Code: MIH
• UDI-Device Identifier: 00613994762238
• UDI-Public: 00613994762238
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 03/12/2014
• Device Model Number: ENBF2516C145E
• Device Catalogue Number: ENBF2516C145E
• Device Lot Number: V01051992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 87 YR