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

Model Number VNMF3428C173TJ

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

Patient Problems Intimal Dissection (1333); Cardiac Tamponade (2226)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: v nmc2525c94tj, serial/lot #: (b)(4), ubd: 09-jul-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant navion stent grafts were implanted in the endovascular treatment of a 141mm chronic thoracic aortic dissection.Vnmc2525c94tj was implanted distally as the first device and vamf3428c173tj was implanted proximally as the second device.It was reported that there was no anomaly was observed at the time of final angiogram , but cardiac tamponade occurred the next day, so an emergency thoracotomy was performed.A retrograde type a aortic dissection (rtad) was also observed & a blood vessel prosthesis was implanted.The patient was receiving treatment in icu.As per the physician the cause of the event can not be determined.No additional clinical sequelae were provided and the patient will be monitored.

• Brand Name: VALIANT NAVION
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10748972
• MDR Text Key: 213470644
• Report Number: 9612164-2020-04114
• 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
• Report Date: 10/28/2020

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: 05/11/2022
• Device Model Number: VNMF3428C173TJ
• Device Catalogue Number: VNMF3428C173TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Date Device Manufactured: 05/11/2020
• 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): Other
• Patient Age: 68 YR