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

Model Number VAMF3434C150TU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Pain (1994); Vascular Dissection (3160)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia was implanted during an endovascular procedure for the treatment of a thoracic aorta ulcer.  it was reported the patient presented emergently with chest pain and shortness of breath.A cta revealed a retrograde type a dissection with fluid in the pericardium. the patient was immediately taken to surgery were the patient underwent an ascending and aortic arch replacement with reimplantation of innominant, right common carotid, and left subclavian artery.The physician removed the free flow stent with wire cutters and sewed the graft to the aorta just proximal to the remaining stent graft.As per the physician the cause of the dissection was due to the free flow stent.This was confirmed during the intervention and on ct.No additional clinical sequelae was provided and the patient is fine.

Manufacturer Narrative

Product analysis conclusion: the reported rtad was confirmed; however, the exact cause could not be determined from the returned films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.It is possible that implantation of the device in the patient¿s acutely angulated arch may have contributed to the occurrence of the rtad.Unknown patient co-morbidities may have also been a factor in the occurrence of this event.Analysis of the returned films did not reveal any obvious out of specification stent graft integrity issues.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

Additional information received: per the physician, the cause of the dissection is not device related but that landing in zone 2 that the angle of the arch with where the free flow stent landed was most likely the cause of the rtad.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 CAPTIVIA - FF
• 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: 13900030
• MDR Text Key: 287890058
• Report Number: 9612164-2022-01168
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346970
• UDI-Public: 00643169346970
• 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,Followup
• Report Date: 05/16/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: VAMF3434C150TU
• Device Catalogue Number: VAMF3434C150TU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 03/25/2022; 04/21/2022
• Supplement Dates FDA Received: 04/15/2022; 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG