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

Model Number	VNMC4646C95TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Valiant captivia stent grafts were implanted during the endovascular treatment of a ruptured thoracoabdominal aortic aneurysm.About 7 years later, follow ct identified growth (3mm in 6 months) at the distal endo of the stent graft in the distal descending thoracic aorta.Intervention was completed.During the procedure the valiant navion graft 46x46x95, sn (b)(4) was advanced and deployed in the thoracic aorta with good overlap with the previously placed endograft.Due to the tortuosity of the aorta, as the graft molded to the aorta, the distal end did move more proximally along the aorta than anticipated, thus an additional navion 46x46x95, was deployed with adequate overlap with the first placed graft.Again, due to tortuosity, the graft did end more proximal to the celiac artery than was desired and the lateral aspect of the distal most part of the graft does not have completely wall apposition.However, seal was obtained for the area above where the dilation was present and there were not endoleaks observed.A ct was was performed last year , where an continued growth and aortic enlargement was observed.A second procedure was performed to treat the event however when attempting to access due to significant calcium and distal aortic plaque significant difficulties were encountered when trying to pass dilators and a decision was made not to proceed as this would lead to open surgery.Per the physician the cause of the enlargement is due to disease progression and there is no complaint against the valiant captivia grafts implanted originally.The cause of the inaccurate delivery was due to patient anatomy.No additional clinical sequalae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: v nmc4646c95tu, serial/lot #: (b)(4), ubd: 27-mar-2021, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 15409033
• Report Number: 9612164-2022-03376
• Device Sequence Number: 14926418
• Product Code: MIH
• UDI-Device Identifier: 00763000101176
• UDI-Public: 00763000101176
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

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: 03/05/2021
• Device Model Number: VNMC4646C95TU
• Device Catalogue Number: VNMC4646C95TU
• 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: 08/18/2022
• Initial Report FDA Received Date: 09/13/2022
• Date Device Manufactured: 03/06/2019
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 66 KG