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

Model Number VNMF4040C223TE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Ulcer (2274)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; penetrating aortic ulcer post migration of thoracic aortic endoprosthesis: case report dinoto et al, international journal of surgery case reports, volume 85, 2021, https://doi.Org/10.1016/j.Ijscr.2021.106219.Implant date: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant navion (40 × 223mm) stent graft system was implanted in a patient during an emergent endovascular procedure for type b aortic dissection (tbad) complicated by symptomatic large infrarenal aaa.Chimney technique was performed for the left subclavian artery and petticoat with evar (endurant ii 32mm stent graft).It was reported that the 12 month follow up ct showed a pau on the little curve of the aortic arch with migration of the prosthesis.Follow up at 15 months showed an increase of pau with partial crush of stent in lsa without significative change of flow in left arm.To prevent further deterioration of the aortic lesion, a secondary procedure was completed.2 non mdt (38 × 150 mm and 42 × 100 mm) stents were placed and deployed in zone 2 of the aortic arch in front of the proximal end of the navion graft.The control angiography confirmed the adequate proximal sealing and the absence of leakages with lsa patency.The procedure was completed with no further complications reported and the patient discharged after 7 days.Per the physician the cause of the pau was possibly due to migration of the endoprosthesis and fragility of the aortic wall.No additional clinical sequelae were reported and the patient is fine.

• 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: 12670981
• MDR Text Key: 277624429
• Report Number: 9612164-2021-04039
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

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 Model Number: VNMF4040C223TE
• Device Catalogue Number: VNMF4040C223TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/21/2021
• 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: 67 YR