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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 VAMC3430C150TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Intimal Dissection (1333)
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
An unknown stent graft was implanted in a patient for the endovascular treatment of a thoracic pau.A valiant stent graft was implanted distally to treat a small extension of the dissection approximately two months later.It was reported the patient phoned technical services to report vessel pressure associated with the valiant stent graft.As per the physician an extension due a distal intima tear was seen in the patient.No additional clinical sequelae were reported and the patient is being monitored.
 
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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 Key8503047
Report Number2953200-2019-00482
Device Sequence Number1955123
Product Code MIH
UDI-Device Identifier00643169346871
UDI-Public00643169346871
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 Year2018
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/11/2019
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 Date01/23/2020
Device Model NumberVAMC3430C150TU
Device Catalogue NumberVAMC3430C150TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2019
Initial Report FDA Received Date04/11/2019
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 Other;
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