Organization name

Cardiac Dimensions, Inc.

SRN

US-MF-000002426

Manufacturer status

Active

15 warnings recorded — scroll inside the panel to see all entries.

• Do not resterilize
• Consult instructions for use
• Do not re-use
• Do not use if package is damaged
• MR CONDITIONAL
• The Carillon Mitral Contour System is contraindicated for use in patients with existing devices in the CS/GCV.

  OTHER

• The Carillon Mitral Contour System is contraindicated for use in patients who have had a mitral valve replacement or have a mitral annuloplasty ring implant.

  OTHER

• If the distal anchor struts are inadvertently collapsed by over advancement of the delivery catheter to the distal anchor twist, recapture and remove the entire implant. See Section 5 – Implant Recapture under IX Implant Procedure.

  OTHER

• The implant cannot be recaptured with the handle assembly once it is decoupled from the handle assembly.

  OTHER

• If, at any point during the procedure, a coronary venogram demonstrates evidence of a clinically significant venous dissection in the implant target zone, terminate the implant procedure and monitor the patient.

  OTHER

• If, at any point during the procedure, a coronary venogram or echocardiogram demonstrates evidence of a clinically significant venous perforation, terminate the implant procedure. Monitor the patient for pericardial effusion and assess the need for pericardial drainage.

  OTHER

• If clinically significant denuded venous tissue is observed on a component of the Carillon Mitral Contour System following implant recapture, terminate the implant procedure. Monitor the patient for pericardial effusion.

  OTHER

• If placement of the implant causes a significant change in the electrocardiogram (ECG), recapture and remove the implant.

  OTHER

• If placement of the implant causes a significant reduction in the coronary arterial dimensions of a clinically significant artery and unresponsive to intracoronary nitroglycerine, then recapture and remove the implant. Confirm a return to baseline arterial dimensions.

  OTHER

• If the patient experiences prolonged third-degree A-V block or asystole at any point during the procedure, terminate the procedure.

  OTHER

Primary placement in Türkiye; available across 14 countries total.

Trade name

Carillon Mitral Contour System (CMCS)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00819833020723

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

081983302CarillonB5

Reference / catalog number

CAT-1516-36

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://cardiacdimensions.com/physicians/instructions-for-use/

Clinical sizes

• 14 mm (distal) x 16 mm (proximal)
• 80 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P0799VASCULAR AND CARDIAC PROSTHESES - OTHER

• Class III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.