MAUDE Adverse Event Report: CORDIS CHEATHEM PLATINUM STENT; AORTIC STENT

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that a type i stent fracture was confirmed in the most proximal and inferior row of zigs in a cordis cheetham platinum stent.The fracture was confirmed on (b)(6) 2011.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CHEATHEM PLATINUM STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): CORDIS
• MDR Report Key: 17524293
• MDR Text Key: 321228078
• Report Number: MW5131240
• Device Sequence Number: 1
• Product Code: PNF
• 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: 08/26/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1