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

Model Number VNMC4343C95TU

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

Patient Problem Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: v nmc3737c90tu, serial/lot #: (b)(4), ubd: 24-feb-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Two valiant navion stent grafts were implanted in the patient during the endovascular treatment of a pau.  it was reported on an unknown date approximately 2 years post the index procedure the physician had completely religned the patient's stent grafts with a non-medtronic graft during an urgent case that was done for  that was done for a symptomatic penetrating ulcer of the thoracic aorta distal to the graft.The graft was also extended distally.  it was stated that the event has resolved.  no cause of the penetrating aortic ulcer was provided.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: VALIANT NAVION
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12630327
• MDR Text Key: 276362956
• Report Number: 9612164-2021-03935
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000101138
• UDI-Public: 00763000101138
• 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
• Report Date: 10/14/2021

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: 07/17/2021
• Device Model Number: VNMC4343C95TU
• Device Catalogue Number: VNMC4343C95TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/14/2021
• Date Device Manufactured: 07/18/2019
• 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): Required Intervention