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

Model Number	VAMF3232C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	09/10/2022
Type of Reportable Event	Death
Event or Problem Description
A valiant captivia stent graft was implanted in the endovascular treatment of a ruptured thoracic aortic dissection and taa.  it was reported that during the index procedure, the valiant captivia stent graft was implanted after a non mdt balloon was used to open the true lumen.A final angiogram performed showed a type iv endoleak.Intervention was performed and the physician implanted another valiant captiva but the endoleak was still remaining.Another  valiant captivia was then implanted and the endoleak was still present.The physician then converted to open surgical repair and sutured a patch on the valiant captivia.The endoleak resolved but after the patient was found to have a more distal dissection and then expired the following day.  no cause of the event was provided.  no additional clinical sequelae were provided and the patient is expired.
Additional Manufacturer Narrative
Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: vamf3232c100tu, serial/lot #: (b)(4), ubd: 16-feb-2023, udi#: (b)(4); product id: vamf3232c200tu, serial/lot #: (b)(4), ubd: 24-mar-2023, udi#: (b)(4).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
Film evaluation summary: the reported endoleak was confirmed; however, the cause and type of endoleak could not be determined from the short video returned.Lack of pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy.Additional video angiograms with a more enhanced imaging resolution, including endoleak interrogation was not provided, therefore it was not possible to perform a thorough assessment of the stent graft in vivo configuration.Although it was not possible to confirm the endoleak type, a type iv endoleak cannot be ruled out.It was noted that the cause of the endoleak was due to high anticoagulant.Factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac are possible contributory factors to type iv endoleaks.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 the patient was being treated for a ruptured type b dissection.Per the physician, the cause of the type iv endoleak was possibly due to high anticoagulant.The cause of the death was heart failure following 6 hours on a cardiopulmonary bypass machine.There was additional delay while t trying to fix that type iv endoleak.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: 15425803
• Report Number: 9612164-2022-03407
• Device Sequence Number: 4679939
• Product Code: MIH
• UDI-Device Identifier: 00643169346987
• UDI-Public: 00643169346987
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2022

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: 02/16/2023
• Device Model Number: VAMF3232C150TU
• Device Catalogue Number: VAMF3232C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 11/24/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/11/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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: Required Intervention; Other; Death
• Patient Sex: Unknown