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

Model Number	ETBF2313C145E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Embolus (1830); Occlusion (1984); Pain (1994)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 ii stent graft system was implanted in a patient for the endovascular treatment an abdominal aortic dissection.It was reported that during a recent follow up a ct revealed that the endurant stent graft was occluded.The patient had a secondary intervention.The physician could access the occluded endurant stent graft with ivus however there was no evidence of compression or kinking.There was well established thrombosis and there were no endovascular treatment available to treat the occlusion, as there was no mechanical issue observed.The physician preformed a femoral to femoral bypass, and the blood flow was restored.The physician stated that the cause of the event could not be determined, as there were no kinks or compression noted.No additional clinical sequelae were reported and the patient is fine.
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
Additional information was received.The patient has experienced pain and other blood clots.
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: 6486942
• Report Number: 2953200-2017-00573
• Device Sequence Number: 1289793
• Product Code: MIH
• UDI-Device Identifier: 00613994991171
• UDI-Public: 00613994991171
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2017

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: 08/17/2018
• Device Model Number: ETBF2313C145E
• Device Catalogue Number: ETBF2313C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided; 04/14/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/12/2017; 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: 59 YR