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

Model Number VNMC2828C90TU

Device Problem Leak/Splash (1354)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumothorax (2012); Rupture (2208); Cardiac Tamponade (2226); Respiratory Failure (2484); Pseudoaneurysm (2605); Vascular Dissection (3160); Thrombocytopenia (4431)

Event Date 12/19/2021

Event Type  Death  

Event Description

Valiant navion stent grafts were implanted in the endovascular treatment of a dissection.  it was reported about 18 months later, the patient presented to the emergency room with hemoptysis.A ct performed revealed a large pseudoaneurysm and type i endoleak.  the patient then expired.Aplastic anemia was also noted.  the cause of the event is unknown.No additional clinical sequalae were provided and the patient is expired.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: v nmf2828c97tu, serial/lot #: (b)(4), ubd: 15-apr-2022, udi#: (b)(4), 1.3 year valid.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.

Manufacturer Narrative

B5; additional information received; it was reported that the subtype of endoleak was not specified, but the endoleak occurred most likely in the distal graft, which is the (b)(6) navion device.There was no endoleak treatment performed prior to the patient's death.The cause of death was multifactorial: aplastic anemia; pulmonary hemorrhage, thrombocytopenia, contained, but worsening aortic rupture, pneumothorax, possible cardiac tamponade physiology from extrinsic heart compression, endograft infection, aortic dissection and acute respiratory failure.2.3 event date updated 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
• 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: 15825603
• MDR Text Key: 303919520
• Report Number: 9612164-2022-04313
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100957
• UDI-Public: 00763000100957
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: VNMC2828C90TU
• Device Catalogue Number: VNMC2828C90TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/15/2022
• Date Device Manufactured: 09/23/2019
• 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): Death
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 71 KG