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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND VALIANT CAPTIVIA; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number VAMC3834C150TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/09/2018
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 thoracic stent graft system was implanted in the patient for an unknown thoracic endovascular treatment.It was reported that the patient had a type ib endoleak.Per the physician, the cause of the event was due to growth of the aneurysm sac.The event was treated by implanting an additional endograft along with 6 heli-fx endoanchors.No additional clinical sequalae were reported and the patient is fine.
 
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Brand Name
VALIANT CAPTIVIA
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7365496
Report Number2953200-2018-00421
Device Sequence Number13992451
Product Code MIH
UDI-Device Identifier00643169346727
UDI-Public00643169346727
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/23/2018
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 Date02/23/2019
Device Model NumberVAMC3834C150TU
Device Catalogue NumberVAMC3834C150TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/27/2018
Initial Report FDA Received Date03/23/2018
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 Age80 YR
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