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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II AUI STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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MEDTRONIC IRELAND ENDURANT II AUI STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR Back to Search Results
Model Number ETUF3614C102E
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Rupture (2208)
Date of Event 05/27/2021
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
An endurant ii aui stent graft was implanted in the emergent treatment of a ruptured unknown sized abdominal aortic aneurysm.It was reported that the rupture was repaired but the patient did not survive.As per the physician the cause of the event is anatomy.No additional clinical sequelae were provided and the patient is expired.
 
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Brand Name
ENDURANT II AUI STENT GRAFT
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI 
MDR Report Key11990020
Report Number9612164-2021-02277
Device Sequence Number3179509
Product Code MIH
UDI-Device Identifier00643169232631
UDI-Public00643169232631
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P100021
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/14/2021
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? No
Operator of Device Health Professional
Device Expiration Date02/16/2023
Device Model NumberETUF3614C102E
Device Catalogue NumberETUF3614C102E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date06/14/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
Patient Age71 YR
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