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Interlock and IDC Detachable Embolization Coils

Indications, Safety, and Warnings

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Fibered IDC – DFU 90962110

Interlock Fibered IDC Occlusion System – DFU 90961055

IDC Interlocking Detachable Coil – DFU 90964372

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Interlock IDC Occlusion System is a modified interlocking detachable coil. The Interlock IDC Occlusion Systems are indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. These devices are not intended for neurovascular use.

CONTRAINDICATIONS

None known.

PRECAUTIONS

Do not attempt to use the Interlock - 35 Fibered IDC Occlusion System with a soft-walled delivery catheter.

Do not advance the Interlock IDC Occlusion System if it becomes lodged within the catheter. Determine the cause of the resistance and replace the catheter and coil if necessary.

ADVERSE EVENTS

The complications that may result from a peripheral embolization procedure include, but are not limited to:

  • Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, nerve and vessel dissection or perforation, etc.)
  • Pain
  • Hemorrhage
  • Infection necessitating medical intervention
  • Foreign body reactions necessitating medical intervention
  • Emboli
  • Ischemia
  • Vasospasm
  • Tissue necrosis
  • Undesirable clot formation of the vasculature
  • Recanalization
  • Death
  • Temporary neurological deficit
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