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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND ENDURANT ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number ENEW2020C82E
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/01/2017
Type of Reportable Event Serious Injury
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of a greater than 5cm dimeter abdominal aortic aneurysm.It was reported that during a recent follow up the ct demonstrated a distal type i endoleak with aneurysm sac expansion.The physician implanted another iliac limb distally and the distal type i endoleak was resolved.Per the physician, the cause of the distal type i endoleak was patient anatomy related, aortic remodeling.No additional clinical sequelae were reported and the patient is fine.
 
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Brand Name
ENDURANT ILIAC STENT GRAFT
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6726997
Report Number2953200-2017-01146
Device Sequence Number1247324
Product Code MIH
UDI-Device Identifier00613994762146
UDI-Public00613994762146
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P100021
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/26/2017
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 Date07/06/2013
Device Model NumberENEW2020C82E
Device Catalogue NumberENEW2020C82E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2017
Initial Report FDA Received Date07/19/2017
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 Required Intervention;
Patient Age67 YR
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