MAUDE Adverse Event Report: CORDIS STENT, CORONARY

Model Number PALMAZ

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Medtronic received information that approximately two years following the implant of a transcatheter pulmonary bioprosthetic valve, it was noted that the cordis palmaz stent appeared fractured.The patient underwent a surgical procedure approximately two months later.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STENT, CORONARY
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): CORDIS
• MDR Report Key: 17523853
• MDR Text Key: 321130515
• Report Number: MW5130801
• Device Sequence Number: 1
• Product Code: MAF
• 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: 08/28/2018

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
• Device Model Number: PALMAZ
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1