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

Model Number VAMC2424C100TJ

Device Problem Leak/Splash (1354)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888); Hemothorax (1896); Shock (2072); Rupture (2208); Vascular Dissection (3160)

Event Date 08/17/2022

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: vamf3632c150tj, serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: vamf3632c150tj, serial/lot #: unknown, ubd: unknown, udi#: unknown.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 chronic type b thoracic dissection.It was reported during the index procedure, vamc2424c100tj + vamf3632c150tj were stacked and placed (the proximal side was directly below the lcca).A junction leakage was observed, so vamf3632c150tj was placed in the inner lining without any problems.Post the procedure the patient went into shock in the icu.Ct scan revealed dsine from the peripheral end of the stent graft placed in the descending aorta; as a result, the false lumen side re-dissociated and it was in a state of 3-chamber dissection.Then, the outer membrane of the false lumen-side dissection vessel was broken, ruptured, and blood accumulated in the chest cavity, resulting in blood loss.Along with dsine, dic also merged, and emergency surgery was discontinued.It was reported the patient expired.Per the physician the cause of the dsine was due to patient vascular morphology.It was noted that it is highly possible that the flap of the dissection was hardened due to chronic dissection; it might have been that the stent graft was placed there, so it could not maintain the shape of the blood vessel, so it was re-dissociated.Without a dic, the stent graft could be extended or artificial blood vessel replacement via thoracotomy, but that was not possible.The cause of death was reported to be due to dsine.The blood vessel's outer membrane was ruptured and blood accumulated in the chest cavity, resulting in death due to blood loss.

Manufacturer Narrative

Additional information received: continuation of d10ç section d information references the main component of the system.Other relevant device(s) are: product id:vamf3632c150tj serial/lot #: (b)(6), ubd: 2023-10-19 , udi#: (b)(4),product id:vamf3632c150tj serial/lot #: (b)(6), ubd: 2023-07-28, 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.

• 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: 15327732
• MDR Text Key: 298976827
• Report Number: 9612164-2022-03231
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/27/2022

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: 03/28/2024
• Device Model Number: VAMC2424C100TJ
• Device Catalogue Number: VAMC2424C100TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/28/2022
• Date Device Manufactured: 03/29/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Male