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

Model Number	ETBF2313C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/08/2018
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 66mm abdominal aortic aneurysm.It was reported the patient presented emergently nearly six years later with a type ia and ib endoleak that had led to a ruptured aneurysm.An emergency intervention procedure was carried out the following day and an aortic cuff, bilateral renal snorkels, endoanchors and bilateral limb extensions were implanted.The event is reported to be resolved.As per the physician the cause of the event is unknown.No additional 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 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: 7964702
• Report Number: 2953200-2018-01465
• Device Sequence Number: 1395361
• Product Code: MIH
• UDI-Device Identifier: 00613994991164
• UDI-Public: 00613994991164
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/10/2019

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: 08/28/2014
• Device Model Number: ETBF2313C124E
• Device Catalogue Number: ETBF2313C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR