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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number ETBF3216C166E
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 of a 103mm diameter abdominal aortic aneurysm.It was reported that a type iii fabric endoleak was noted in the bifurcate.It was noted that the patient received treatment with a femoral-femoral bypass and aui conversion, with limb extension and endoanchors implantation.This resolved the event.As per the physician, the cause of the type iii endoleak is not determined.No additional clinical sequelae were reported and the patient is fine.
 
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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 Key7353464
Report Number2953200-2018-00395
Device Sequence Number16579738
Product Code MIH
UDI-Device Identifier00613994990990
UDI-Public00613994990990
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P100021
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2018
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 Date04/11/2015
Device Model NumberETBF3216C166E
Device Catalogue NumberETBF3216C166E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2018
Initial Report FDA Received Date03/20/2018
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 Age77 YR
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