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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 TREATMENT
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MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number VNMC3434C223TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/22/2020
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
A valiant navion stent graft was implanted for a 30-40 mm thoracic aortic dissection.It was reported that approximately 3 days later, a ct was performed and a type ia endoleak was observed.Ballooning was then performed proximally which resolved the endoleak.As per the physician the cause of the event was that the pigtail catheter during the index procedure was not placed in the proximal aspect of the graft and as a result the leak was not seen then.No additional clinical sequalae were provided and the patient is fine.
 
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Brand Name
VALIANT NAVION
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key10275354
Report Number9612164-2020-02589
Device Sequence Number2234054
Product Code MIH
UDI-Device Identifier00763000260828
UDI-Public00763000260828
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/15/2020
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 Date05/20/2022
Device Model NumberVNMC3434C223TU
Device Catalogue NumberVNMC3434C223TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2020
Initial Report FDA Received Date07/15/2020
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 Age65 YR
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