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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 VAMF3838C150TU
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/27/2019
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 was implanted in a patient for the endovascular treatment of a 55 mm thoracic abdominal aneurysm.It was reported that when the patient returned for follow up approximately 2 years 2 months later, distal expansion of the aneurysm was reported.Intervention was carried out two days later, with an extension implanted distally to seal the aneurysm.As per the physician, the cause of the event was not device related.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 Key8496417
Report Number2953200-2019-00474
Device Sequence Number16457222
Product Code MIH
UDI-Device Identifier00643169346956
UDI-Public00643169346956
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P100040
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/09/2019
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? No
Operator of Device Health Professional
Device Expiration Date09/20/2018
Device Model NumberVAMF3838C150TU
Device Catalogue NumberVAMF3838C150TU
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 Date04/09/2019
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 Required Intervention;
Patient Age70 YR
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