Indications, Safety, and Warnings
Indications for use
Caution:
This device should be used only by physicians with a thorough understanding of angiography and/or percutaneous neurointerventional procedures.
Indications For Use (US):
The Pipeline™ Vantage Embolization Device with Shield Technology™ is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
The Pipeline™ Vantage Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
Contraindications: 1) Patients with active bacterial infection. 2) Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is contraindicated. 3) Patients who have not received antiplatelet agents prior to the procedure. 4) Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. 5) Patients in whom the parent vessel size does not fall within the indicated range.
Warnings:
1) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Vantage Embolization Device with Shield Technology™ implant. 2) Person with known allergy to platinum alloy (including major elements platinum, tungsten, iridium), tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline™ Vantage Embolization Device with Shield Technology™ delivery system. 3) Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection and compromised device performance. 4) Post-procedural movement (migration and/or foreshortening) of the Pipeline™ Vantage Embolization Device with Shield Technology™ implant may occur following implantation and can result in serious adverse events and/or death. 5) Factors which may contribute to post procedural device movement include (but are not limited to) the following: Failure to adequately size the implant (i.e., under sizing), failure to obtain adequate wall apposition during the implant deployment, implant stretching, vasospasm, severe vessel tapering, tortuous anatomy. 6) Delayed rupture may occur with large and giant aneurysms. 7) Placement of multiple Pipeline™ Vantage Embolization Device with Shield Technology™ may increase the risk of ischemic complications. 8) Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in difficulty or inability to deploy the Pipeline™ Vantage Embolization Device with Shield Technology™ and can lead to damage to the Pipeline™ Vantage Embolization Device with Shield Technology™ and microcatheter. Advancement or retraction of the Pipeline™ Vantage Embolization Device with Shield Technology™ against resistance may result in damage, including unintended device or component, separation, fracture, or breakage of the deliver system due to inherent flexibility limits of device design. Device damage may result in patient injury or death. Refer to page 4 in the instructions for use for additional information. 9) Do not attempt to reposition the device after full deployment. 10) The benefits may not outweigh the risks of treatment of small and medium asymptomatic extradural intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not negligible. 11) A decrease in the proportion of patients who achieve complete aneurysm occlusion without significant parent artery stenosis has been observed with the use of the device in the communicating segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)), including those IAs fed by the posterior circulation or have retrograde filling. Ensure appropriate patient selection and weigh the benefits and risks of alternative treatments prior to use of this device for the treatment of intracranial aneurysms located in this region of the ICA. The following anatomical characteristics, associated with retrograde filling, should be carefully considered during procedural planning of C7 intracranial aneurysms: 1. PComm of fetal origin (A PCA of fetal origin is defined as a small, hypoplastic, or absent P1 segment of the PCA with the PComm artery supplying a majority of blood flow to the ICA); 2. PComm overlapping with the aneurysm neck; and/or 3. PComm branch arising from the dome of the aneurysm. 12) Pipeline™ Vantage Embolization Device with Shield Technology™ has not been tested for radial artery access. Radial artery access should only be used when femoral artery access is not feasible. 13)For additional Materials of Concerns information such as CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship .
Precautions:
1) The Pipeline™ Vantage Embolization Device with Shield Technology™ should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopic equipment. 2) Physicians should undergo appropriate training prior to using the Pipeline™ Vantage Embolization Device with Shield Technology™ in patients. 3) The Pipeline™ Vantage Embolization Device with Shield Technology™ is intended for single use only. Carefully inspect the sterile package and device components prior to use to verify that they have not been damaged during shipping. 4) Do not use kinked or damaged components. 5) Do not use product if the sterile package is damaged. 6) Use the Pipeline™ Vantage Embolization Device with Shield Technology™ system prior to the “Use-by date” printed on the package. 7) The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice. 8) A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy. 9) Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. 10)The Pipeline™ Vantage Embolization Device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. 11) Take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible. 12) Carefully weigh the benefits of treatment vs. the risks associated with treatment using the device for each individual patient based on their medical health status and risks factors for intracranial aneurysm rupture during their expected life time such as age, medical comorbidities, history of smoking, intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging, presence of multiple intracranial aneurysms, and presence of concurrent pathology.The benefits of device use may not outweigh the risks associated with the device in certain patients; therefore, judicious patient selection is recommended. 13) The safety and effectiveness of the device has not been established for treatment of fusiform IAs. 14)There may be a decrease in effectiveness and increase in safety events when the device is used in patients ≥ 60 years old. 15) The safety and effectiveness of the device has not been evaluated or demonstrated for ruptured aneurysms.
Potential Complications:
Potential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to the following:
Access site complications such as hematoma, pain, retroperitoneal hemorrhage, skin discoloration, nerve damage, abscess, edema; Adverse reactions to antiplatelet/anticoagulation agents, contrast media, or anesthesia such as pain, hemorrhage, organ failure, aspiration, nausea; Cardiac complications such as arrhythmia, myocardial infarction; Compartmental complications such as brain edema, intracranial hypertension, mass effect, hydrocephalus; Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia; Device complications such as kink, stretching, device fracture, device migration, device misplacement, friction, foreign body in patient, premature deployment, inadequate deployment, premature detachment, non-detachment; Hematologic complications such as coagulopathy, thrombosis, hemolysis, intracranial hemorrhage; Neurological deficits or dysfunctions such as headache, seizures, coma, emotional changes, paresis, transient ischemic attack, stroke; Systemic complications such as fever, infection, inflammation, edema, shock, toxicity, hypersensitivity, allergic reaction, organ failure, hypotension, hypertension, pain; Decreased therapeutic response including need for target aneurysm treatment; Vascular complications such as dissection, perforation, rupture, ischemia, vasospasm, stenosis, necrosis, granuloma, fistula, pseudoaneurysm, occlusion, thromboembolism, embolism including to unintended territory; Visual complications such as transient blindness, blindness, diplopia, reduced visual acuity/field, retinal artery occlusion, retinal ischemia, retinal infarction, scintillations, blurred vision, eye floaters; Death.
*Consult instructions for use for other therapy devices and medications for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.
US-NNP-2400080 (v1.0)
