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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number VAMF3232C200TU
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/31/2017
Type of Reportable Event Serious Injury
Event or Problem Description
An valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 25.0 cm thoracic aortic dissection.It was reported that a type ib endoleak was discovered.The patient had a distal extension placed on with visceral stenting (celiac, left renal, and sma).Per the physician, the cause of the endoleak was due to the patient anatomy.No additional clinical sequelae were reported and the patient is fine.
 
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Brand Name
VALIANT CAPTIVIA - FF
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6819815
Report Number2953200-2017-01326
Device Sequence Number68634
Product Code MIH
UDI-Device Identifier00643169347137
UDI-Public00643169347137
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 Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/31/2017
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 Date09/19/2018
Device Model NumberVAMF3232C200TU
Device Catalogue NumberVAMF3232C200TU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2017
Initial Report FDA Received Date08/25/2017
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 Age66 YR
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