Pipeline™ Flex Embolization Device with Shield Technology™ INDICATIONS, SAFETY, AND WARNINGS

INDICATIONS FOR USE

The Pipeline™ Flex embolization device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms.

CAUTION

• This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopic equipment.
• The Pipeline™ Flex embolization device with Shield Technology™ should be used by physicians who have received appropriate training for this device.
• Carefully inspect the sterile package and the Pipeline™ Flex embolization device with Shield Technology™ prior to use to verify that neither has been damaged during shipment. Do not use kinked or damaged components.
• The Pipeline™ Flex embolization device with Shield Technology™ is not to be used after the expiration date imprinted on the product label.
• Do not reprocess or resterilize. Reprocessing and resterilization increase the risks of patient infection and may compromise device performance. 
• If high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously. Advancement of the Pipeline™ Flex embolization device with Shield Technology™ against resistance may result in damage or patient injury.
• The presence of other indwelling endovascular stents may interfere with proper deployment and function of the Pipeline™ Flex embolization device with Shield Technology™.
• Under fluoroscopy, carefully monitor the tip coil during Pipeline™ Flex embolization device with Shield Technology™ deployment.
• If the delivery wire cannot be retracted into the micro catheter, carefully remove the delivery wire and micro catheter simultaneously.
• If the catheter cannot be advanced through the Pipeline™ Flex embolization device with Shield Technology™, carefully remove the delivery wire through the Pipeline™ Flex embolization device with Shield Technology™ construct.

PRECAUTIONS

• Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.
• Do not attempt to re-position the Pipeline™ Flex embolization device with Shield Technology™ after deployment past the resheathing marker. 
  
• Placement of multiple Pipeline™ Flex embolization devices with Shield Technology™ may increase the risk of ischemic complications.
  
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
  
• A thrombosed aneurysm may aggravate pre-existing, or cause new, symptoms of mass effect and may require medical therapy.
  
• Do not place the Pipeline™ Flex embolization device with Shield Technology™ in patients whom a pre-existing stent is in place in the parent artery at the target aneurysm location.
  
• Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risks due to incomplete foreshortening resulting in an implant longer than anticipated.
  
• Person with known allergy to cobalt/chromium alloy (including major elements of cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to the Pipeline™ Flex embolization device with Shield Technology™ implant.
  
• Person with known allergy to tin, silver, stainless steel or silicone elastomer may suffer an allergic reaction to the Pipeline™ Flex embolization device with Shield Technology™ delivery system.
  

CONTRAINDICATIONS

• Patients who have not received antiplatelet agents prior to the procedure.
• Patients with active bacterial infection.
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• The Pipeline™ Flex embolization device with Shield Technology™ should not be used alone as sole therapy for acutely ruptured aneurysms.

COMPATIBILITY

The Pipeline™ Flex embolization device with Shield Technology™ is designed to be delivered through a compatible 0.027 (0.69 mm) inside diameter micro catheter. Unconstrained diameter of the Pipeline™ Flex embolization device with Shield Technology™ is 0.25 mm greater than the labeled diameter (on the packaging). Do not use the Pipeline™ Flex embolization device with Shield Technology™ in vessel diameters that are larger than the labeled diameter.

The fluorosafe marker is only compatible with micro catheters with a minimum length of 135 cm.

MAGNETIC RESONANCE IMAGING

Non-clinical testing has demonstrated that the Pipeline™ Flex embolization device with Shield Technology™ is MR Conditional. It can be scanned safely under the following conditions:

• Static magnetic field of 3 Tesla or less.
• Spatial gradient field of 720 Gauss/cm or less.
• Maximum whole-body-averaged specific absorption rate (SAR) of 4.0 W/kg for 15 minutes of scanning.

In non-clinical testing, the Pipeline™ Flex embolization device with Shield Technology™ produced a temperature rise of less than 0.6°C at a maximum whole body averaged specific absorption rate (SAR) of 4.0 W/kg assessed by calorimetry for 15 minutes of MR scanning in a 3 Tesla MR 750 GE Signa 20.0 System MR Scanner.

The Pipeline™ Flex embolization device with Shield Technology™ may create local field inhomogeneity and susceptibility artifacts which may degrade the diagnostic quality of the MRI images. Based on the non-clinical testing of the 5.0 mm device using standard views, the worst case maximum artifact was < 4 mm when subjected to 3.0 Tesla. Local field artifact from the Pipeline™ Flex embolization device with Shield Technology™ may decrease the accuracy of MR angiogram in assessing vessel luminal patency.

MR image quality may be compromised if the area is in the exact same area or relatively close to the position of the Pipeline™ Flex embolization device with Shield Technology™. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, the following:

• Adverse reaction to antiplatelet/anticoagulation agents or contrast media
• Ischemia
• Blindness
• Mass effect
• Coma
• Neurological deficits
• Death
• Parent Artery Stenosis
• Device fracture
• Perforation
• Device migration or misplacement
• Perforator occlusion
• Dissection of the parent artery
• Post-procedure bleeding
• Distal embolization including to a previously uninvolved territory
• Ruptured or perforated aneurysm
• Embolism
• Seizure
• Groin injury
• Stroke
• Headache
• Thromboembolism
• Hemorrhage
• Transient Ischemic Attack (TIA)
• Hematoma or hemorrhage at the puncture site
• Vasospasm
• Hydrocephalus
• Vessel occlusion
• Infection
• Vessel perforation
• Intracerebral bleeding
• Vision impairment
• Chronic pain
• AV fistula
• Pseudoaneurysm

WARNINGS

• Pushing delivery wire without retracting the micro catheter at the same time will cause the open end braid to move distally in the vessel. This may cause damage to the braid or vessel.
• Resheathing the Pipeline™ Flex embolization device with Shield Technology™ more than 2 full cycles may cause damage to the distal or proximal ends of the braid.