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

Model Number VAMC3228C150TJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802)

Event Date 05/29/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft was implanted in a patient for the endovascular treatment of an unknown sized thoracic aortic aneurysm.A non-mdt stent graft was also implanted during the procedure.It was reported during the index procedure after the valiant navion was successfully implanted the non-mdt stent graft was placed at the target position.It was reported that just before implantation, bradycardia and cardiac arrest occurred.Angiography was performed and confirmed the presence of aortic regurgitation.Percutaneous cardiopulmonary support (pcps) was carried out.The symptoms recovered temporarily by using cardiac massage and a defibrillator and pcps was stopped.Angiography was performed again and the non-mdt stent graft implanted successfully.Angiography was performed again and confirmed that the aortic regurgitation persisted, and cardiac arrest then re-occurred.Pcps was restarted and intra-aortic balloon pumping (iabp) was also used to assist with circulation.The patient was transferred to the intensive care unit and was reported to have expired three days post the index procedure.As per the physician, the patient has a medical history of heart failure and poor heart condition.It was unable to be concluded at what point the aortic regurgitation occurred.It was considered, however, that there was the possibility the guide wire used during the procedure may have made contact with and damaged the aortic valve during the implantation of the non-mdt stent graft.No additional clinical sequalae were reported and the patient is expired.

Manufacturer Narrative

Additional information: temporary pacing was also started when pcps was first commenced.It was confirmed that there was no direct cause of death reported as no autopsy was performed.Pcps was used for cardiac arrest and iabp was used for assisted circulation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• 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: 9685746
• MDR Text Key: 178302560
• Report Number: 9612164-2020-00625
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/28/2020

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 Expiration Date: 02/10/2021
• Device Model Number: VAMC3228C150TJ
• Device Catalogue Number: VAMC3228C150TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/28/2020
• Date Device Manufactured: 02/11/2019
• 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