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

Model Number	VNMC3737C182TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Insufficient Information (4580)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant navion stent graft was implanted for the endovascular treatment of a thoracic aortic dissection and thoracic aortic aneurysm.  it was reported the patient returned for a ct one week post the index procedure which showed the lumen had increased, there was no sign of  an endoleak or increase of aorta.The physician decided to carry out an intervention to extend the stent by implanting a valiant navion stent graft 3 months post the index procedure.Approximately 17 months post the index procedure the patient returned for a ct and persistent false lumen filling and aorta enlargement was observed.The physician intervened with extension of the stent grafts and the case was resolved.Recent ct taken approximately 4 years post the index procedure is normal.   as per the physician the cause of the false lumen perfusion and aorta enlargement was due to the use undersized stent grafts.No additional clinical sequalae was provided and the patientis fine.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v nmc3737c182tu, serial/lot #: (b)(4), ubd: 04-dec-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• Common Device Name: 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: 14539988
• Report Number: 9612164-2022-02044
• Device Sequence Number: 6774425
• Product Code: MIH
• UDI-Device Identifier: 00763000101060
• UDI-Public: 00763000101060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: VNMC3737C182TU
• Device Catalogue Number: VNMC3737C182TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/30/2022
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 88 KG