Safety Information – Ovation

Ovation Safety Information

← Back

Indications for Use

The Ovation Abdominal Stent Graft System is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including:

  • Adequate iliac/femoral access compatible with vascular access techniques (femoral cut-down or percutaneous), devices, and/or accessories
  • Proximal aortic landing zone
    • with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery
    • with an aortic angle of ≤ 60 degrees if proximal neck is ≥10 mm and ≤ 45 degrees if proximal neck is <10 mm
  • Distal iliac landing zone
    • with a length of at least 10 mm
    • with an inner wall diameter of no less than 8 mm and no greater than 25 mm

Contraindications

  • Patients who have a condition that threatens to infect the graft.
  • Patients with known sensitivities or allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol).
← Back

MRI Safety and Compatibility

The Ovation Abdominal Stent Graft System is determined to be MR Conditional

Non-clinical testing applicable to the Ovation Abdominal Stent Graft System demonstrated that the device is MR Conditional. A patient with this device can be scanned safely, immediately after placement under the following condition

Static magnetic field of 1.5 or 3.0-Tesla, only

  • Maximum spatial gradient magnetic field of 4,000-Gauss/cm or less
  • Maximum MR System reported whole-body averaged specific absorption rate (SAR) of 2-W/kg (Normal Operating Mode) for 15 minutes of scanning (i.e., per pulse sequence)

In non-clinical testing applicable to the Ovation Abdominal Stent Graft System, the test article produced the following temperature rises during MRI performed for 15-min of scanning (i.e., per pulse sequence) in 1.5-Tesla/64-MHz (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:

1.5-Tesla 3-Tesla
MR system reported, whole body averaged SAR 2.9-W/kg 2.9-W/kg
Calorimetry measured values, whole body averaged SAR 2.1 -W/kg 2.7-W/kg
Highest temperature change +2 °C +2.4 C T
Temperature scaled to whole body averaged SAR of 2-W/kg 1.4°C 1.7°C

These temperature changes will not pose a hazard to a patient under the conditions indicated above.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Ovation iX Abdominal Stent Graft System. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 5 mm relative to the size and shape of this implant, both inside and outside the device lumen.

Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size 9,305-mm2 1,011-mm2 13,082-mm2 1,514-mm2
Plane Orientation Parallel Perpendicular Parallel Perpendicular
← Back

Warnings and Precautions

  • The Ovation Abdominal Stent Graft System is for single patient use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure that 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, 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.
  • Accurate fluoroscopic imaging is required during any endovascular procedure and for proper device deployment. Implantation of this device should occur in an operating room, endovascular suite, catheterization laboratory, or similar sterile environment, with appropriately trained personnel, and suitable equipment and imaging capabilities. Do not use this device if the patient is unable to be evaluated using the necessary preoperative and postoperative imaging.
  • The Ovation Abdominal Stent Graft System should only be used by physicians and teams experienced in endovascular techniques and who have been trained in its use. Always have a qualified surgery team available during implantation or re-intervention procedures in the event that conversion to open surgical repair is necessary.
  • The long-term performance of this implant has not been established. All patients treated with this device must undergo periodic imaging to evaluate stent graft integrity and position, aneurysm size, and potential endoleaks and/or, occlusion of vessels in the treatment area. Significant aneurysm enlargement, a persistent endoleak, the appearance of a new endoleak, device migration, reduced blood flow through the graft, and/or decrease in renal function due to renal artery occlusion should prompt further investigation into the need for further patient treatment, including additional intervention or surgical conversion. Additional patient imaging follow up should be considered for patients with devices that have effectiveness issues. All patients should be carefully counseled on the need for long-term follow up. The device is not recommended in patients unable or unwilling to comply with the information in Follow-up Imaging Recommendations.
← Back

Adverse Events

Adverse events that may occur and/or require intervention include but are not limited to:

Acute and chronic renal failure, renal microembolism, renal insufficiency, renal artery occlusion, contrast toxicity, allergic reaction and/or anaphylactoid response to x—ray contrast dye, anti-platelet therapy, device materials, anesthetic complications and subsequent attendant problems (aspiration); aneurysm enlargement or rupture, blood or bleeding events such as, anemia, gastrointestinal bleeding, retroperitoneal bleeding, bowel events such as bowel ischemia, infarction, bowel necrosis, colon ischemia, paralytic or adynamic ileuses, obstruction, fistulas, cardiac events and subsequent attendant problems such as congestive heart failure, volume overload, arrhythmias, myocardial infarction, chest discomfort or angina, elevations in creatinine phosphokinase (CPK), hypotension, hypertension, cerebral events (local or systemic) and subsequent attendant problems such as change in mental status, cerebrovascular accident (hemorrhagic or embolic), reversible ischemic neurologic deficit, nerve injury, transient ischemic attacks, paraplegia, paraparesis, paralysis, death, device events such as deployment or device malfunction stent fracture, loss of stent graft system component integrity, graft twisting and/or kinking, graft material wear, dilation, erosion, puncture, endograft occlusion, migration, dislodgement, endoleak, embolic and thrombotic events (with transient or permanent ischemia or infarction) such as deep vein thrombosis, thromboembolism, microembolism, thrombophlebitis, phlebothrombosis, air embolism, general discomfort related to the procedure, generalized inflammatory response that may be associated with elevated levels of systemic mediators of inflammation, elevated temperature, genitourinary complications and subsequent attendant problems such as ischemia, erosion, fistula, incontinence, hematuria, infection, hepatic failure, insertion and other vascular access site complications such as infection, dissection, transient fever, bleeding, pain, delayed healing, abscess formation, hematoma, dehiscence, seroma, cellulitis, nerve injury/damage, neuropathy, neuralgia, vasovagal response, pseudoaneurysm, anastomotic false aneurysm, arteriovenous fistula, impotence/ sexual dysfunction, lymphatic complications and subsequent attendant problems such as lymphocele, lymph fistula, multi-system organ failure, neoplasm, operative and post operative bleeding and hemorrhage, coagulopathy; paralysis (temporary or permanent) such as paraplegia, monoplegia, paresis, spinal cord ischemia, hemiplegia, bowel or bladder incontinence, pericarditis, pneumothorax, possible infection—urinary tract, systemic or localized, endog raft; pulmonary/respiratory events and subsequent attendant problems such as pulmonary insufficiency, pneumonia, respiratory depression or failure, pulmonary edema, pulmonary embolism, atelectasis, pleural effusion; radiation injury, late malignancy, sepsis, seroma; shock; spinal neurological deficit; surgical conversion to open repair; and/or vascular spasm or vascular injury/trauma including damage to blood vessels and surrounding tissues, atherosclerotic ulcer, vessel dissection, perforation, plaque dissection, stenosis, pseudoaneurysm, vessel occlusion, embolization, ischemia, tissue loss, limb loss, gangrenous disease, worsened or new onset claudication, edema, fistula, bleeding, rupture, death.

Please reference product Instructions for Use and more information regarding indications, warnings, precautions

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

810-0017-01-01