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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 VAMC3838C150TU
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Death (1802); Vascular Dissection (3160)
Type of Reportable Event Death
Additional Manufacturer Narrative
Date of death unknown.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 the patient for the endovascular treatment of a thoracic dissection.It was reported that the patient presented emergently on approximately and a type a retrograde dissection was diagnosed.The patient received an unknown treatment.The patient expired on an unknown date.As per the physician, the cause of the dissection of death is undetermined.No additional clinical sequelae were reported.
 
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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 Key7353577
Report Number2953200-2018-00396
Device Sequence Number19108330
Product Code MIH
UDI-Device Identifier00643169346840
UDI-Public00643169346840
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) 03/20/2018
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? No
Operator of Device Health Professional
Device Expiration Date12/18/2019
Device Model NumberVAMC3838C150TU
Device Catalogue NumberVAMC3838C150TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/22/2018
Initial Report FDA Received Date03/20/2018
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 Death; Required Intervention;
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