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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR Back to Search Results
Model Number VNMF2525C96TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Rupture (2208)
Date of Event 09/05/2021
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
A valiant navion stent graft was implanted in an unknown endovascular procedure.  it was reported approximately 1 year post the index procedure, the patient died due to a endoleak and rupture.  no cause was reported.  no additional clinical sequelae were provided and the patient is expired.
 
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Brand Name
VALIANT NAVION
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI 
MDR Report Key12645918
Report Number9612164-2021-03977
Device Sequence Number1443207
Product Code MIH
UDI-Device Identifier00763000260347
UDI-Public00763000260347
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 10/18/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date10/08/2022
Device Model NumberVNMF2525C96TU
Device Catalogue NumberVNMF2525C96TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date10/18/2021
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; Other;
Patient Age78 YR
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