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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number ETLW1620C124E
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/31/2017
Type of Reportable Event Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a greater than 5.5 cm abdominal aortic aneurysm.It was reported that a type ib endoleak from the left limb was observed at a follow up appointment.An intervention was performed and a 16x13x93 extension was placed.This reportedly resolved the event.The physician stated that the cause of the event was vessel dilation.No additional clinical sequelae were reported and the patient is fine.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ENDURANT II ILIAC STENT GRAFT
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6819808
Report Number2953200-2017-01324
Device Sequence Number13463934
Product Code MIH
UDI-Device Identifier00613994991645
UDI-Public00613994991645
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 Year2014
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/01/2017
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 Date03/26/2016
Device Model NumberETLW1620C124E
Device Catalogue NumberETLW1620C124E
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/31/2017
Supplement Date Received by Manufacturer09/01/2017
Initial Report FDA Received Date08/25/2017
Supplement Report FDA Received Date09/26/2017
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 Age88 YR
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