MAUDE Adverse Event Report: MEDTRONIC VASCULAR MEDTRONIC NAVION STENT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Medtronic aorta stent failed, caused a type iii endoleak causing my aorta to enlarge, requiring urgent surgery.My aorta is still, after surgery, enlarged to a life threatening size.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC NAVION STENT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 15003758
• MDR Text Key: 295904768
• Report Number: MW5110837
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/10/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Patient Sequence Number: 1
• Treatment: CENTRUM SILVER MENS VITAMINS; METOPROLOL- MEDICAL MANAGEMENT OF DESCENDING AORTIC DISSECTION
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White