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

Model Number	VAMF2828C150TU
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent graft was implanted during the endovascular treatment of a thoracic dissection. the patient has an existing non mdt dacron graft.It was reported the patient returned for a follow-up approximately 8 weeks post the index procedure.Ct identified a proximal peak irregularity.It was noted that the proximal crown of the free flo valiant captivia seemed to protrude slightly through the patients existing dacron graft present in the arch.It was reported one day later the patient presented to er with chest pain.Ct then revealed greater protrusion of the valiant graft's proximal peak through the existing dacron graft and extravasation of contrast.No type ia endoleak was found.The next day the patient was taken to or for an open repair.Patient is currently in icu.Per the physician the cause of the protrusion is undetermined.No additional clinical sequalae was provided and the patient will be monitored.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
B5; additional information received : it was reported that migration did not occur.The patient had an ascending aortic dissection repair in april with open replacement of the aortic arch and debranching followed by tevar and placement of a petit coat stent.Operative notes lists the following procedures performed during the intervention procedure: emergent ecmo initiation; emergent redo sternotomy; aortogram, pelvic angiogram; aortic arch repair; innominate vein patch repair; left thoracotomy with pericardial window.It was stated in the op notes that ¿an area of bleeding where it appeared that the proximal stent had eroded through the suture line (of dacron graft)¿.The patient remains in icu.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
• 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: 15162072
• Report Number: 9612164-2022-02936
• Device Sequence Number: 6599816
• Product Code: MIH
• UDI-Device Identifier: 00643169347007
• UDI-Public: 00643169347007
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 04/08/2023
• Device Model Number: VAMF2828C150TU
• Device Catalogue Number: VAMF2828C150TU
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/13/2022
• Date Device Manufactured: 04/08/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male