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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - CW; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND VALIANT CAPTIVIA - CW; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number VAMC4646C150TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/25/2018
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 stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, ct showed a type ib endoleak, 20mm above the celiac artery.Intervention was performed on the same day and the patient received a valiant 46mm distal extension.The endoleak was confirmed resolved.Per the physician, the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient is fine.
 
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Brand Name
VALIANT CAPTIVIA - CW
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7792828
Report Number9612164-2018-02085
Device Sequence Number11156405
Product Code MIH
UDI-Device Identifier00643169346802
UDI-Public00643169346802
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/17/2018
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 Date02/07/2020
Device Model NumberVAMC4646C150TU
Device Catalogue NumberVAMC4646C150TU
Device Lot NumberV07591051
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date08/17/2018
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;
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