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

Model Number	ETUF2314C102E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984)
Date of Event	09/06/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: catalog # etlw1610c93e, serial number: (b)(4), use by date 2019-01-23 and (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 aui stent graft system was implanted in a patient for the endovascular treatment of a 60mm in diameter abdominal aortic aneurysm.It was reported that the patient presented emergently.The stent graft was thrombosed so an intervention was performed to explant the graft.During the secondary procedure, the patient expired from hyperkalemia and rhabdomyolysis.Per the physician, the patient was a heavy smoker that continued to smoke post graft implant which most likely caused the thrombosis.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ie
• MDR Report Key: 6899952
• Report Number: 2953200-2017-01518
• Device Sequence Number: 1183164
• Product Code: MIH
• UDI-Device Identifier: 00643169232556
• UDI-Public: 00643169232556
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 12/07/2018
• Device Model Number: ETUF2314C102E
• Device Catalogue Number: ETUF2314C102E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 09/28/2017
• 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: Death; Required Intervention
• Patient Age: 59 YR