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

Model Number VNMC4646C95TU

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

Patient Problems Anemia (1706); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 07/30/2022

Event Type  Death  

Event Description

A patient presented with worsening shortness of breath.An ecg performed demonstrated a 5.4- cm aortic root dilated ascending aorta and a bicuspid aortic valve with moderate mixed aortic valve disease as well as mild mitral regurgitation.The patient then underwent a bentall¿s procedure and mitral valve annuloplasty.There were no complications in the postoperative period, and the sternotomy wound had healed in the 12 months after surgery.Four years later, the patient represented with a discharging sternal sinus, secondary to infection of the sternal wires with staphylococcus aureus, resulting in chronic sternal osteomyelitis.This was managed with sternal wound debridement, removal of the superior infected sternal wires, antibiotics and negative pressure wound therapy, and then subsequent conventional dressings.Four weeks after removal of the superior sternal wires the patient re-presented to hospital complaining of chest pain, dizziness, and multiple episodes of active bleeding from the sternal wound.The patient was found to have a swollen chronically infected sinus over the sternotomy scar with evidence of a hematoma.A ct was then performed which showed a pseudoaneurysm at the distal anastomosis of the ascending graft and rim-enhancing soft tissue surrounding the aorta.The appearances were in keeping with sternal wound infection having extended to the ascending aortic bio graft forming a pseudoaneurysm, with the development of an aorto-cutaneous fistula through the osteomyelitic sternum and to the infected skin sinus.Following review , it was decided to treat the patient endovascularly as a temporary measure to optimize the patient before major cardiac revision surgery and to allow time for long term antibiotics to suppress the graft infection.A valiant navion stent graft was flushed with a anti mycobacterial, and inserted into the patient followed by deployment under rapid pacing conditions.A completion angiogram demonstrated exclusion of the pseudoaneurysm.A ct angiogram performed 48 hours later and demonstrated successful covering of the pseudoaneurysm at the anterior aspect of the ascending aorta.The infectious disease team advised long term antibiotic use and the patient was discharged 2 days later with an extensive follow-up care plan.Two months later, the patient re-presented in septic shock.The patient was hypotensive, tachycardia, tachypneic and pyrexic and had abnormal blood results.A ct demonstrated a new infected pseudoaneurysm at the proximal end of the previously implanted stent graft, still with intact ascending graft proximal to the pseudoaneurysm.Further intervention was performed and a valiant navion stent graft was implanted under rapid pacing.The ct angiogram day 6 after surgery demonstrated that the pseudoaneurysm was successfully covered with the valiant stent graft.Three months later after the second endovascular repair, the patient re presented with sternal wound bleeding , hemoptysis and dizziness.The patients hemoglobin was low and required a blood transfusion.Ct angiography demonstrated extension of the pseudoaneurysm superior to the stent graft and up to the level of the brachiocephalic trunk, as well as an empyema.The patient subsequently made the decision not to proceed with any further surgery and declined antibiotic therapy.Under palliative care, the patient died 7 months after the first endovascular stent graft procedure.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; aorto-cutaneous fistula of the ascending aorta- case report and a literature review of endovascular management gormley s, zaman z, mani k & khashram k journal of vascular surgery cases, innovations and techniques volume 9 (1) 100971 https://doi.Org/10.1016/j.Jvscit.2022.06.023 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.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: 16415815
• MDR Text Key: 309940926
• Report Number: 9612164-2023-00790
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 02/22/2023

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: VNMC4646C95TU
• Device Catalogue Number: VNMC4646C95TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/22/2023
• 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): Death; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female