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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 VAMF4040C150TE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiomyopathy (1764); Death (1802); Heart Failure (2206); Respiratory Failure (2484); Pseudoaneurysm (2605)
Event Date 07/19/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vamf4238c150te, serial # unknown, ubd: unknown, udi #: unknown.(b)(4).Medtronic received the following information obtained from the journal article entitled: midterm follow-up geometrical analysis of thoracoabdominal aortic aneurysms treated with multilayer flow modulator giovanni spinella.Alice finotello, elena faggiano, bianca pane, michele conti, valerio gazzola, ferdinando auricchio and domenico palombo, genoa and pavia, italy annals of vascular surgery 2018; 53: 97¿104.Doi.Org/10.1016/j.Avsg.2018.04.034.If information is provided in the future, a supplemental report will be issued.
 
Event Description
An endurant stent graft and two valiant captivia stent grafts were implanted in a patient for the endovascular treatment of a type ii thoracoabdominal aortic aneurysm.Two mfm (multilayer flow modulator) devices were also implanted in the patient.A re-intervention was performed on an unknown date for excessive aneurysm growth observed after completion of the patients two-year follow-up and an additional mfm device was implanted.It was hypothesised that the increasing aneurysm diameter may have been due to non-optimal porosity of the mfm.The patient also underwent the deployment of an aortouni-liac custom-made device with embolization of the contralateral iliac artery to treat a pseudoaneurysm at the distal anastomosis of a previous aortoaortic bypass graft (open surgery performed 5 years before).Follow up after the re-intervention procedure showed stabilization of the aneurysm diameter.The article also reported that two of the seven patients died of cardiac and respiratory failure after three years.The patient who died of respiratory failure also had ischemic cardiomyopathy.It is unknown if either of these patients had a medtronic device implanted.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
VALIANT CAPTIVIA - FF
Type of Device
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key8105730
MDR Text Key128403900
Report Number2953200-2018-01628
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
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
Device Operator Health Professional
Device Model NumberVAMF4040C150TE
Device Catalogue NumberVAMF4040C150TE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/31/2018
Initial Date FDA Received11/27/2018
Supplement Dates Manufacturer Received10/31/2018
01/17/2019
Supplement Dates FDA Received11/27/2018
01/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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