PHIL™ Indications, Safety, and Warnings

Warnings and Precaution

WARNINGS

• Performing embolization to occlude blood vessels is a high-risk procedure. This device should be used only by physicians with neuro or peripheral interventional training and a thorough knowledge of the vascular pathology to be treated, vascular architecture, angiographic techniques, and super-selective embolization techniques.

• Vascular malformation embolization may influence or change blood flow patterns, thereby subjecting arteries supplying the vascular malformation or the normal surrounding tissues and perivascular space around the malformation to increased pressures, or by causing an increase in the intra-nidal pressure. These conditions could result in hemorrhagic complications.

• Care must be taken to avoid venous outflow occlusion prior to nidal or arterial feeders as this may also produce malformation hemorrhage. If the PHIL device extravasates outside the vascular space, secondary to vessel wall compromise, a sub-acute inflammatory response to the material may occur in the surrounding vascular space which may lead to tissue damage.

• There may be some topical hypersensitivity and/or release of histamines from Dimethyl Sulfoxide (DMSO).

• Therapeutic embolization should not be performed when high blood flow precludes safe delivery of the embolic agent to prevent non-target embolization.

• The microcatheter tip should be placed as distal as possible, and as close to the target vascular lesion as possible to prevent any non-target embolization of normal surrounding tissue or cranial nerves.

• Premature solidification of the PHIL device may occur if the microcatheter or luer hub comes in contact with any solution such as saline, blood or contrast.

• Use only DMSO compatible microcatheters indicated for use in the neuro or peripheral vasculature. Other microcatheters or syringes may not be compatible with DMSO and their use can result in thromboembolic events due to microcatheter degradation.

• Use only the Terumo Neuro pre-filled syringes to inject DMSO and the PHIL device. Other syringes may not be compatible with DMSO.

• Rapid injection of DMSO into the vasculature space may lead to vasospasm and/or angionecrosis. In the event of microcatheter occlusion, excessive force to advance the plunger may result in microcatheter rupture due to over pressurization.

• Do not allow more than 1 cm of the PHIL device to reflux back over microcatheter tip. Excessive reflux may result in difficult microcatheter removal.

• After using a microcatheter with the PHIL device, do not attempt to clear or inject any material through it. Such attempts may lead to embolus or non-target embolization.

• STOP injection if the PHIL device is not visualized exiting the microcatheter tip. If the microcatheter becomes occluded, over-pressurization and vessel rupture can occur. During injection, continuously verify under fluoroscopy that the PHIL device is exiting the microcatheter tip.

• STOP injection if increased resistance is observed. If increased resistance occurs, determine the cause (e.g. occlusion in microcatheter lumen) and replace the microcatheter if needed. Do not attempt to clear or overcome resistance by applying increased injection pressure, as use of excessive pressure may result in microcatheter or vessel rupture and embolization of non-target areas.

• Only use thumb pressure to inject the PHIL device. Using the palm of hand to advance plunger may result in microcatheter or vessel rupture due to over pressurization in the event of microcatheter occlusion.

• DO NOT interrupt the PHIL device injection for longer than three minutes prior to re-establishing injection. This may cause solidification of the PHIL device within the microcatheter tip resulting in microcatheter occlusion. Use of excessive pressure to clear the microcatheter may result in microcatheter or vessel rupture and embolization of non-target areas.

• Do not use if the packaging is opened or damaged.

• Caution is to be used for nickel-sensitive and/or pregnant female patients, as the device packaged in glass syringes may contain Nickel.

CAUTIONS

• Do not use if packaging is opened or damaged.

• This device is intended for single use only. Do not reuse, reprocess, or re-sterilize.

Reuse, reprocessing, or re-sterilization may compromise the integrity of the device and /or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• After use, dispose in accordance with hospital, administrative and/or local government policy.

PRECAUTIONS

• The safety and effectiveness have not been studied in the following patient populations:

  • Pregnant and nursing women

  • Individuals less than 18 years old

  • Individuals with feeding pedicle aneurysms not associated with the nidus, or distal feeders to the nidus or vascular malformation.

• Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications.

• A garlic-like taste may be noted by the patient with use of the PHIL device due to the DMSO component. This taste may last several hours. An odor on the breath and skin may be present.

• Inspect product packaging prior to use. Do not use if sterile barrier is open or damaged.

• Use prior to expiration date.

• Verify that the microcatheters and accessories (see directions for use) used in direct contact with the PHIL polymer are clean and compatible with the material and do not trigger polymerization or degrade with contact. Use only DMSO compatible microcatheters indicated for use in the neuro or peripheral vasculature, and Terumo Neuro sterile, prefilled syringes. Other microcatheters or syringes may not be compatible with DMSO and their use can result in thromboembolic events due to microcatheter degradation. Refer to the Warnings and Directions for Use sections.

• Upon completion of the PHIL device injection, wait three minutes, slightly aspirate the syringe, and then gently pull the microcatheter to separate it from the PHIL cast. Failure to wait this recommended time to retrieve the microcatheter after injection may result in fragmentation of the PHIL device into non-target vessels.