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

Model Number VNMC3434C90TE

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problems Hemothorax (1896); Low Blood Pressure/ Hypotension (1914); Pain (1994); Paralysis (1997); Pneumonia (2011); Rupture (2208)

Event Date 12/10/2021

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: vnmc4034c200te, serial/lot #: (b)(4), ubd: 06-feb-2021, udi#: (b)(4); product id: vnmc4337c200te, serial/lot #: (b)(4), ubd: 14-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant navion stent grafts were implanted during an unknown endovascular procedure.  it was reported the patient attended emergently with chest pain and hemothorax.It was reported that the stent graft had slipped.Intervention was completed where carotid-carotid bypass was carried out and the graft was relined due to a thoracic rupture with loss of proximal seal.Post the intervention the patient status was reported as paraplegic, possibly hypotension related.Per the physician the cause of the rupture and loss of seal are undetermined.It was further reported that the patient developed multiple pulmonary setbacks, bilateral pneumonia and passed away.No additional clinical sequelae were reported and the patient has expired.

Manufacturer Narrative

It was reported via corelab that from imaging dated the 10 of dec and 27th of dec 21, a type ia endoleak was observed on the stent graft with sn (b)(6).Aortic enlargement was noted as +13.8mm and +10.9mm from the two imaging dates respectively.There was no stent fracture or stent ring enlargement noted.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: 13223125
• MDR Text Key: 283582177
• Report Number: 9612164-2022-00144
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: 05/19/2021
• Device Model Number: VNMC3434C90TE
• Device Catalogue Number: VNMC3434C90TE
• Device Lot Number: V29469061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/10/2022
• Date Device Manufactured: 05/20/2019
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG