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

Device Problems Leak/Splash (1354); Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/30/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: salvage of an incomplete sandwich with a covered celiac trunk and a ¿floating¿ superior mesenteric artery stent in a thoracoabdominal aortic aneurysm gouveia e melo et al, ournal of endovascular therapy 2023, vol.30(6) 951¿956 https://doi.Org/10.1177/15266028221090448 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 Description

A valiant navion stent graft was implanted in a patient during the endovascular repair of 79mm type v taaa using a sandwich technique (chimney for the celiac trunk (ct) and superior mesenteric artery (sma).) on an unknown date.Non medtronic grafts were also implanted during the procedure.It was reported during the index procedure, the navion graft was implanted lower than intended covering the celiac trunk.The sma was stented with a non medtronic stent and left inside the main thoracic graft, without completing the sandwich technique.A second attempt was made at catheterizing the ct to complete the repair but was unsuccessful and the patient was referred to another center.Ct-angiography at the referring center showed a patent but covered ct, a patent sma with a long stent facing upward inside the thoracic aortic graft and a significant type ib endoleak where the thoracic graft was not sealing distally with no increase in size.A staged procedure was completed where firstly the aorta external to the graft was catharized followed with catechization of the ct.Non medtronic stents was placed into the ct and sma and control angiography showed correct placement and patency of both sma and ct stents.The procedure was completed by completing a fenestrated and branched repair using a non-medtronic graft with no endoleaks observed.Postoperative recovery was uneventful, and the patient was discharged 8 days after surgery.The first-month ct-angiography showed exclusion of the aneurysm, patency of all stents, and target vessels, with no signs of target vessel instability, endoleaks, or mural thrombus.

• Brand Name: VALIANT NAVION
• 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: 19201339
• MDR Text Key: 341259680
• Report Number: 9612164-2024-02032
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/29/2024
• 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: 83 YR
• Patient Sex: Male