How to Implant the ReTAP™ Patch

Handling

Peel open the sterile pouch and carefully remove the patch using sterile, atraumatic instruments or gloves. It is not necessary to pre-clot the ReTAP™ Patch.

Sizing

The ReTAP™ Patch is intended for peripheral vascular patching for vessels that are approximately 6 to 10 mm in diameter and where a curved patch is desired. Do not form a larger patch by suturing separate patches together since doing so may result in an inadequate implantation result.

Suturing

It is recommended only non-absorbable, monofilament, suture with a non-cutting, tapered, needle of appropriate size be used. Use a minimum 2 mm suture bite in cardiac and great vessel applications. For peripheral applications, use a minimum 1 mm suture bite. Use appropriate suture size and placement to prevent gaps. Use minimal tension when pulling up on the suture line or when placing a knot. This will minimize suture line bleeding. Use the smallest needle that is appropriate for the procedure.

Contraindications

The ReTAP™ Cardiovascular Patch is not indicated for:

  • Reconstruction of hernias and tissue deficiencies.
  • Reconstruction and repair of passive biological membranes such as duramater, pericardium, or peritoneum.

Use of this product in non-cardiovascular applications can potentially cause complications, for example: failure of closure or repair, suture pull out, or undesired healing to surrounding tissues.

Precautions

  • Do not use absorbable sutures.
  • Do not use a cutting needle.
  • Do not use less than a 2 mm suture bite in all cardiac and great vessel applications.
  • Do not use less than a 1 mm suture bite in all peripheral applications.
  • Do not contaminate or damage the patch.
  • Suture line bleeding may occur if suture holes are elongated, torn, or if large gaps are allowed to form between the prosthetic material and the native tissue.
  • Only qualified physicians in cardiovascular surgery techniques should use the prosthesis.
  • The healthcare provider is responsible for all appropriate postoperative care instructions to the patient.