Contraindications; Potential Complications - COOK Medical Biodesign Mode D'emploi

BIODESIGN® FISTULA PLUG
DEVICE DESCRIPTION
The Biodesign® Fistula Plug is a tapered small intestinal submucosa (SIS)
cylinder with an SIS button. The SIS button is fastened to the wide end of the
cylinder with resorbable polyglycolic acid (PGA) suture. The plug is used to
reinforce soft tissue for the repair of anorectal fistulas. Once implanted, the
natural composition of SIS allows for the patient's healing mechanisms to
deposit cells and collagen during cellular and extracellular matrix metabolism.
Publications by Ellis et al.
fistula tract or fluid observed in 75% (6/8) and 49% (54/110) of patients,
respectively, under MRI visualization 12-months after plug implantation. This
is consistent with histological evidence in which patients' tissues completely
incorporate SIS material over 7-17 months, resulting in new, remodeled
tissue. 3-5 The plug can be cut to size to accommodate the patient's anatomy
and is provided sterile for single use only.
INTENDED USE
The Biodesign Fistula Plug is for implantation to reinforce soft tissue for repair
of anorectal fistulas. The plug is supplied sterile and is intended for one-time
use.
This symbol means the following:
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
This symbol means the following: Magnetic Resonance Safe
This product is intended for use by medical professionals trained in the repair
of anorectal fistulas.

CONTRAINDICATIONS

• The plug is derived from a porcine source and should not be used for
patients sensitive to porcine materials.
• Not for vascular use.
PRECAUTIONS
• The plug is designed for single use only. Attempts to reprocess, resterilize,
and/or reuse may lead to failure and/or transmission of disease.
• Do not resterilize. Discard all open and unused portions.
• The plug is sterile if the package is dry, unopened and undamaged. Do not
use if the package seal is broken.
• Discard the plug if mishandling has caused possible damage or
contamination or if the plug is past its expiration date.
• Do not implant the plug in a grossly infected or abscessed fistula tract.
• A seton should be used until there is no evidence of acute
inflammation, purulence, or excessive drainage. Allow the tract to
stabilize and mature for at least six to eight weeks before placing the
plug.
• Ensure that the plug is hydrated prior to placement, cutting, or suturing.
• Placement of the plug in fistula tracts less than 1 cm in length can result in
incomplete incorporation and/or expulsion.
• No studies have been conducted to evaluate performance of the plug in
pediatric populations.
• No studies have been conducted to evaluate the reproductive impact of
the clinical use of the plug.
GENERAL
• Users should be familiar with surgical technique for anorectal fistula repair.
• Users should exercise good surgical practice for the management of clean-
contaminated, contaminated or infected fields.
• Risk of infection following implantation may be reduced by debriding the
fistula tract prior to plug insertion.
• IMPORTANT: Users should instruct patients to abstain from strenuous
physical activity for at least six weeks after plug placement.
• Expect some drainage for two to four weeks. Drainage can continue
for up to 12 weeks after the procedure as the plug incorporates and
the fistula tract closes.

POTENTIAL COMPLICATIONS

Complications that can occur with the use of the plug include:
• Abscess
• Allergic reaction
• Bleeding
• Delayed or failed incorporation of the plug • Pain
• Erosion
• Extrusion
1 and Jayne et al. 2 report no evidence of residual
3
ENGLISH
• Infection
• Inflammation
• Migration
• Redness
• Sepsis