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

Model Number VAMF4646C200TU

Device Problem Leak/Splash (1354)

Patient Problems Hemothorax (1896); Insufficient Information (4580)

Event Date 08/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A valiant navion stent graft was implanted during intervention of a type ia endoleak present in a previously implanted navion stent graft after the patient presented emergently with severe chest pain on (b)(6) 2021.A procedure to debranch the proximal aorta was performed.The patient was taken to the or where a graft was placed on the proximal ascending arch to the great vessels.After that procedure the patient was transferred to the hybrid lab where the physician placed a 46x46x200 valiant down the ascending landing down to the bypass.The distal end of the graft landed in the mid portion of the previous implanted devices.The post angiogram showed no endoleak.The procedure was completed and the patient was removed from the or.*during the original index procedure on (b)(6) 2019 a navion stent was implanted in the endovascular treatment of a ruptured thoracic aortic aneurysm.On (b)(6) 2021 an additional navion stent graft was implanted proximally during intervention for a suspected type iiib/ia endoleak and aneurysm enlargement(50mm-70mm) and susptected stent ring enlargement in a different area of the graft and it appeared like the stent had come off the graft.The patient had been complaining of chest pain.On the (b)(6) 2021 it was reported the patient presented emergently with severe chest pain.The patient was given a heart cath but the patient was still experiencing severe pain, a ct showed a type ia endoleak.*it was noted that the patient had a 3 intervention on an unknown date (after the (b)(6) 2021 intervention) where a non mdt (gore) stent graft was implanted at some point in the proximal portion of the graft.The graft was placed at the level of the left carotid and a proximal type 1 endoleak was present.* on (b)(6) 2021 the ct was reviewed as it was reported the patients chest tube had filled with blood, it was determined the type ia was still present.Another intervention was performed on (b)(6) 2021 where an additional 46x46x200 device was implanted, it was reported the physician performed a cut down in order to get extra length for the device to get closer to the bypass graft, the graft and junctions were then aggressively ballooned and the procedure was completed.It was reported per the physician the cause of the endoleak was anatomy due to aneurysmal degeneration.No additional clinical sequalae were reported and the patient is fine.

Manufacturer Narrative

The core lab review of imaging from (b)(6) 2021, (12 month follow up) showed aortic enlargment, no endoleak, no fractures and yes;no to stent enlargment.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: 12431933
• MDR Text Key: 270049391
• Report Number: 9612164-2021-03442
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• 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
• Report Date: 11/16/2021

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: 02/22/2023
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/16/2021
• Date Device Manufactured: 02/22/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male