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

Model Number	ETBF2813C124E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	02/24/2017
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 endovascular treatment of an abdominal aortic ulcer.It was reported that the patient presented with right leg pain.The patient was diagnosed with occlusion of the endurant stent graft.The physician implanted a balloon expandable stent from the right ipsilateral limb to the right common iliac artery at the level of the aortic bifurcation.The event was resolved.The patient re-presented with right leg pain.There was stent graft occlusion.The physician performed a femoral-femoral graft bypass and the blood flow was restored.The physician stated that the cause of the event was related to the patient¿s anatomy, tight stenosis pre procedure.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6447646
• Report Number: 2953200-2017-00492
• Device Sequence Number: 13660507
• Product Code: MIH
• UDI-Device Identifier: 00613994991287
• UDI-Public: 00613994991287
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2018
• Device Model Number: ETBF2813C124E
• Device Catalogue Number: ETBF2813C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Required Intervention
• Patient Age: 61 YR