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

Model Number UNK-CV-SR-VAL-NAV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pneumonia (2011); Renal Failure (2041)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Valiant navion stent grafts were implanted in two patients in the endovascular treatment of a complex type a aortic dissection.In total 81 patients were included in the study.This study compared the clinical outcomes of two operative strategies for this disease: hybrid approach of ascending aorta (and hemiarch replacement) supplemented with retrograde stenting of the descending aorta (thoracic endovascular aortic repair [tevar]) and standard ascending aorta (and hemiarch) replacement without stent placement.The hybrid technique where the valiant navion and non mdt stent graft were implanted applied to 30 patients in the group while 51 patients received standard surgical repair only.The median proximal and distal stent diameter were 28.7 and 28 mm, respectively.The median treatment length was 127 mm.The following adverse events were reported;  blood loss, stroke, acute kidney injury, pneumonia  , re-intervention  patient mortality was reported but there is no causal link that  valiant stent graft caused or contributed to any death.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; mid-term outcomes of a hybrid approach involving open surgery plus tevar of the descending aorta in the treatment of complex type a dissection li j, stadlbauer a, terrazas a.Floerchinger b, pfister k,  creutzenberg m,  oikonomou k,  schmid  c,  rupprecht l.  thoracic and cardiovascular surgeon vol.70.(8) 2022 pp.607-615 doi https://doi.Org/ 10.1055/s-0042-1743592.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.A.2 <(>&<)> a.3 average  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 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: 18235953
• MDR Text Key: 329316098
• Report Number: 9612164-2023-05687
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VAL-NAV
• Device Catalogue Number: UNK-CV-SR-VAL-NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 11/30/2023
• 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): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male