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

Catalog Number	VAMF3434C150TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Necrosis (1971); Pulmonary Edema (2020)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a valiant captivia stent graft was implanted for the treatment of a type b thoracic aortic dissection.No damage was noted to the device or device box prior to the procedure.It was noted that prior to deployment, ivus and angiography were performed.The physician could see the innominate, left carotid and left subclavian, but could not identify the celiac trunk and the right renal artery was already out before the procedure started.The valiant captivia was initially intended to land at the left carotid.The graft was advanced to the desired landing area and there was about 1cm landing zone at the left carotid artery.While the stent was being deployed, it kicked back and landed at the left subclavian artery.It was confirmed that the deployment steps were followed per the instructions for use.Subsequent angiography showed that the graft was in the false lumen.The physician believes that the graft was deployed in the false lumen after the wire crossed over from the true to the false lumen before deployment.No i ntervention was performed.It was not possible to reposition the stent as it was deployed in the false lumen.The device remains implanted.The patient was put on comfort care.It was reported that bowel necrosis occurred and the patient was having concomitant issues.The patient's lungs filled with fluid and put under extra corporeal membrane oxygenation (ecmo) therapy.
Additional Manufacturer Narrative
Correction to b5; the previously reported sentence: "the right renal artery was already out before the procedure started" should read as follows: "the patient's right renal was not functioning before the procedure started." medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 21418846
• Report Number: 9612164-2025-00905
• Device Sequence Number: 21131959
• Product Code: MIH
• UDI-Device Identifier: 00643169346970
• UDI-Public: 00643169346970
• 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: 2025
• 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): 02/25/2025

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: 06/21/2026
• Device Catalogue Number: VAMF3434C150TU
• 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: 02/16/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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
• Patient Age: 47 YR
• Patient Sex: Male