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

Model Number VNMC3131C182TU

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Blood Loss (2597); Insufficient Information (4580)

Event Date 09/21/2020

Event Type  Death  

Manufacturer Narrative

Concomitant of product: information references the main component of the system.Other relevant device(s) are: product id: vnmc3131c182tu, serial/lot #: (b)(4), ubd: 15-may-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant navion stent graft system was implanted for the endovascular treatment of a thoracic dissection.The dissection measured from the lsa to iliac bifurcations.It was reported approximately 4 months post the index procedure, follow up ct demonstrated that the graft was distal to the lcca and had a type ia endoleak.During the initial procedure the graft appeared to be 5mm distal to the lcca and the final angiogram confirmed seal and the decision was made not to extend at that time however now the graft appears to have migrated distal leading to a type ia endoleak.The patient underwent aortic arch debranching and endograft placement from the ascending aorta into the existing descending thoracic graft.Vnmc4034c200tu ((b)(4)) was used.It was then reported one day later the patient started bleeding out of the mediastinal tube.The patient was rushed to the operating room and opened where it was noted that the proximal end of the graft had perforated the aorta.Multiple repair stitches were placed but would not hold in the fragile aorta and the patient continued to suffer blood loss and expired.Per the physician the cause of the migration was user error.

Manufacturer Narrative

Product analysis conclusion; the reported proximal endoleak could be confirmed on the films provided; however the cause of the event could not be determined.Earlier post-implant ct¿s, after the index procedure, were not provided for assessment of the stent grafts original in vivo configuration.It was not possible to determine whether migration of the stent graft was a factor in the occurrence of the endoleak.From the measurements of the proximal aortic flow lumen, it is possible that a larger size stent graft could have been implanted in the patient and may have prevented the reported migration of the device.Lack of pre-implant ct¿s and sizing sheet plan did not allow for a thorough assessment of the pre-implant anatomy.Analysis of the returned films did not reveal any obvious out of specification stent graft integrity issues.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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 10676701
• MDR Text Key: 211237644
• Report Number: 9612164-2020-03909
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100988
• UDI-Public: 00763000100988
• 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,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: VNMC3131C182TU
• Device Catalogue Number: VNMC3131C182TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• 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: 58 YR