Potential Adverse Events; Individualization Of Treatment; Patient Counseling Information - Medtronic Tri-Ad 900SFC Instrucciones De Uso

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
■
This device was designed for single patient use only. Do not reuse,
reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device
and/or create a risk of contamination of the device, which could result
in patient injury, illness, or death.

6. Potential Adverse Events

While infrequent, certain complications have been reported when using
annuloplasty ring. These include the following:
■ uncorrected or recurrent regurgitation
■
stenosis
■ ring dehiscence
■
hemolysis (even with mild regurgitation)
■
low cardiac output
■
heart block
■
damage to coronary arteries
■
endocarditis
■
thrombosis
■ thromboembolism
■
anticoagulant-related hemorrhage
■ ring fracture
■
leaflet perforation
■ bleeding diathesis
The potential for these complications should be considered when
selecting the most beneficial surgical procedure for each patient. To avoid
or minimize occurrence of these adverse events, the annuloplasty repair,
including sizing and implantation, should be conducted in accordance
with the methods described in these Instructions for Use by surgeons with
appropriate training and experience in valve repair.

7. Individualization of Treatment

To allow for healing and incorporation of the annuloplasty ring by host
tissue, regardless of cardiac rhythm, postoperative anticoagulation
therapy should be considered for at least six weeks following surgery.

8. Patient Counseling Information

8.1. Patient Dental Care
Patients with annuloplasty rings who undergo dental or other potentially
bacteremic procedures must be considered for prophylactic antibiotic
therapy.
14 Instructions for Use
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