Potential Adverse Events; Packaging; Sjm™ Séguin Annuloplasty Ring; Sjm™ Séguin Annuloplasty Ring Sizer Set Model Sar-501 - St.Jude Medical SJM Seguin SARP-24 Mode D'emploi

POTENTIAL ADVERSE EVENTS

As with prosthetic heart valves, serious complications may be associated with
the use of this device, sometimes leading to death. Complications necessitating
re-operation may occur at varying intervals and include: thrombus, hemolysis, ring
fracture, left ventricular outflow tract obstruction, systolic anterior motion, damage
to coronary arteries, stenosis, uncorrected or recurrent regurgitation, partial or
complete dislodgment of the ring from its site of attachment, thromboembolism,
A-V block, endocarditis, low cardiac output, and bleeding disorders relating to the
use of anticoagulant therapy.

PACKAGING

SJM™ Séguin Annuloplasty Ring
SJM™ Séguin Annuloplasty Ring is supplied sterile, and mounted on a plastic
holder. The ring and the holder are contained in a double-barrier clear pouch that
facilitates handling and transfer to the sterile field.
The ring remains sterile until the "USE BY" date on the packaging, if package
integrity is maintained.
The package includes:
• One (1) SJM™ Séguin Annuloplasty Ring with identification tag, mounted on a
plastic holder
• One (1) instruction for use
• One (1) medical device registration form
• Inner and outer pouches
SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501
The sizer set is supplied non-sterile. Each sizer set includes:
• One (1) holder handle
• One (1) extension handle
• Nine (9) sizers, 24 mm – 40 mm, even sizes.
• One (1) autoclavable tray with cover
• One (1) instruction for use

STORAGE

To minimize the possibility of contamination and to provide maximum protection,
the ring should be stored in the double-barrier pouch in a cool, dry place until
needed.
The sizer set may be stored indefinitely.

SURGICAL CONSIDERATIONS

• Only surgeons who have adequate training to determine whether incompetent
heart valves are capable of being repaired, or if replacement is indicated, should
use the SJM™ Séguin Annuloplasty Ring.
• The decision to undertake annuloplasty can be made only after visual analysis
of the valve pathology.
• Only surgeons who have received appropriate training in valve repair, including
ring implant and sizing techniques, should perform valve repair using the SJM™
Séguin Annuloplasty Ring.
• Surgeons should be aware that annular calcium may prevent the use of
the SJM™ Séguin Annuloplasty Ring unless the calcium can be safely and
completely excised.
• Surgeons who use annuloplasty rings should be current on all anticoagulation
regimes.
• Suture techniques may vary according to the preferences of the implanting
surgeon and the needs of the patient.
• Intraoperative echocardiography is recommended to assess valvular
competency and quality of mitral repair.
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