MAUDE Adverse Event Report: ANDRAMED ANDRASTENT; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Event Description

Medtronic received information that over 4 years following the implant of this andrastent, endocarditis was diagnosed.An echocardiogram revealed thrombotic floating structures at the distal stent with free moving leaflets.Distal stent fractures were noted with stent struts in the right lung.A second bioprosthetic pulmonary valve was implanted valve-in-valve.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ANDRASTENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ANDRAMED
• MDR Report Key: 17523514
• MDR Text Key: 321099815
• Report Number: MW5130462
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1