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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 VNMF4040C62TU
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/10/2019
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 was then implanted in a patient.It was reported the patient expired about 2 weeks later due to an unknown cause.The patient had been transferred to another facility and lost to follow-up.It was said it could not be determined if the device contributed to the patients death.No cause was reported.No additional clinical sequalae 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 Key12082754
Report Number9612164-2021-02515
Device Sequence Number14542657
Product Code MIH
UDI-Device Identifier00763000100704
UDI-Public00763000100704
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 06/29/2021
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? No
Operator of Device Health Professional
Device Expiration Date10/14/2020
Device Model NumberVNMF4040C62TU
Device Catalogue NumberVNMF4040C62TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/01/2021
Initial Report FDA Received Date06/29/2021
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;
Patient Age63 YR
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