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

Model Number VNMC4040C55TU

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

Patient Problem Intimal Dissection (1333)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant navion stent graft was implanted in a patient for the endovascular treatment of a thoracic aortic ulcer.It was reported that the patient had a good 1 week post operative scan, however presented with an ascending aortic dissection at the 1 month scan.The dissection was visible proximal to and behind the implanted device.The patient has not received treatment, as the physician opted for observation.As per the physician, the cause of the event may be device oversizing, but feels the issue relates to the imh and weak tissue in the patient's anatomy.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information: it was reported that the ulcer was located proximal to the lsa and the proximal end of the stent graft was implanted in zone 0 of the ascending aorta.It was reported that 10-20% stent graft oversizing was used.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• 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: 8206317
• MDR Text Key: 131719454
• Report Number: 9612164-2018-03790
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000101084
• UDI-Public: 00763000101084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

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 Expiration Date: 10/07/2020
• Device Model Number: VNMC4040C55TU
• Device Catalogue Number: VNMC4040C55TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/31/2019
• Date Device Manufactured: 10/08/2018
• 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): Hospitalization
• Patient Age: 88 YR