MAUDE Adverse Event Report: CORDIS STENT, CORONARY

Model Number UNKNOWN

Device Problem Crack (1135)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Event Description

Medtronic received information that approximately one-year post implant of the stents, the patient had a cardiac catheterization performed.Echocardiogram showed increasing right ventricular pressures, and intracardiac echocardiogram revealed no thrombosis.Fractures were seen in the stents and a balloon aortic valvuloplasty (bav) was performed.It was planned to bring the patient back for future stenting.Approximately five months later two new stents were placed and was noted that the patient practices shibari.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: 17532473
• MDR Text Key: 321131206
• Report Number: MW5139381
• 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: 11/12/2018

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
• Device Model Number: UNKNOWN
• Patient Sequence Number: 1