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

Model Number VAMC4444C200TU

Device Problems Fracture (1260); Leak/Splash (1354); Positioning Problem (3009)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Pain (1994); Hypovolemia (2243)

Event Date 08/30/2022

Event Type  Death  

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.

Event Description

Valiant captivia stent grafts were implanted in a patient for the endovascular treatment of a 70mm thoracic aneurysm.An open arch repair was also preformed.Approximately 4 years later 3 navion stent grafts were implanted.A severe angulated neck was noted.It was reported approximately 6 years post the index procedure, an intervention procedure was performed to reline a previous valiant stent graft (implanted in 2016) due to a fractured graft with a type iiib endoleak and sac increase (100mm).It was noted the patient also presented with pain pre the intervention procedure.During the intervention the physician was unable to advance the graft (vamc4444c200tu) through the fractured graft from the femoral approach.The physician used the apex approach however due to the angulated arch the graft could not be advanced.The patient became hemodynamically unstable with bradycardia and hypovolemia and went into cardiac arrest.Resuscitation was unsuccessful and the patient expired.Per the physician the cause of the fracture, type iiib endoleak and death are undetermined.

• Brand Name: VALIANT CAPTIVIA - CW
• 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: 15354683
• MDR Text Key: 299261377
• Report Number: 9612164-2022-03283
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346444
• UDI-Public: 00643169346444
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 09/05/2022

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: 07/20/2023
• Device Model Number: VAMC4444C200TU
• Device Catalogue Number: VAMC4444C200TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/05/2022
• Date Device Manufactured: 07/20/2021
• 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): Death; Required Intervention