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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 ETLW1613C93E
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code Occlusion (1984)
Date of Event 12/05/2019
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 an unknown diameter abdominal aortic aneurysm.It was reported that an occlusion of the etlw1613c93e limb was noted.The patient was treated for thrombosis using a pta and non-medtronic balloon.The occlusion was then resolved.As per the physician, the cause of the occlusion was possibly inadequate dilation of the limb.No additional clinical sequelae were reported and the patient is fine.
 
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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 Key9444503
Report Number9612164-2019-05083
Device Sequence Number10882665
Product Code MIH
UDI-Device Identifier00643169467682
UDI-Public00643169467682
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P100021
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/10/2019
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 Date03/13/2021
Device Model NumberETLW1613C93E
Device Catalogue NumberETLW1613C93E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2019
Initial Report FDA Received Date12/10/2019
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 Age61 YR
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