MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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.

• 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 Key: 8105730
• MDR Text Key: 128403900
• Report Number: 2953200-2018-01628
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• 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 Number: VAMF4040C150TE
• Device Catalogue Number: VAMF4040C150TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 01/17/2019
• Supplement Dates FDA Received: 11/27/2018; 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 Number: 1
• Patient Outcome(s): Death; Required Intervention