Contegra™ Pulmonary Valved Conduit - Medtronic, Inc International Section

Contegra® Pulmonary Valved Conduit

Indications, Contraindications, Warnings, Precautions and Adverse Events

Contegra® Pulmonary Valved Conduit

INDICATIONS

The Contegra® conduit is indicated for implantation into patients under 18 years of age presenting with the following clinical conditions:

Correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in congenital heart malformations (e.g., pulmonary atresia, pulmonary stenosis, tetralogy of Fallot, etc.).
Pulmonary valve replacement during the Ross procedure.
Replacement of a previously implanted but dysfunctional pulmonary homograft or a failed pulmonary prosthesis.

CONTRAINDICATIONS

The Contegra® conduit is contraindicated for use in the following clinical conditions:

Patients 18 years of age and older needing RVOT-reconstructive surgery, Ross procedure or replacement of dysfunctional pulmonary homograft or failed pulmonary prosthesis.
Left heart surgical procedures.
If, after the physician assesses the risk-to-benefit ratio, established alternative medical or surgical techniques suggest superior clinical results.

WARNINGS

FOR SINGLE USE ONLY.
DO NOT RESTERILIZE THE CONDUIT BY ANY METHOD.
Exposure of the conduit and its container to irradiation, steam, ethylene oxide, or other chemical sterilants will render the conduit unfit for use.
DO NOT use the conduit under the following conditions:

the conduit has been dropped, damaged, or mishandled in any way
the "Use By" date has elapsed
the seal is broken
the serial number tag does not match the container label
the conduit has been exposed to freezing or to prolonged heat (Check freeze indicator. If exposed to a freeze - thaw condition, the indicator vial will break causing the dye to escape and stain the paper backing.)
the storage solution does not completely cover the conduit

DO NOT expose the conduit to solutions other than the storage and rinsing solutions.
DO NOT allow the conduit to dry. Maintain conduit moisture with irrigation or immersion during surgery.
DO NOT attempt to repair a damaged conduit.
DO NOT use cutting needles, as they may cause structural damage to the conduit.
DO NOT pass a catheter through the conduit, as this may damage the conduit.

Caution: Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure or breathing of the chemical vapor. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water (minimum of 15 minutes). In the event of eye contact, flush with water for a minimum of 15 minutes and seek medical attention immediately.

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