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Stent misalignment of the Zenith Dissection Endovascular System
Luca Bertoglio1, Germano Melissano, Efrem Civilini
1Division of Vascular Surgery, "Vita - Salute" University, Scientific Institute H. San Raffaele, Milan, Italy. l.bertoglio@hsr.it
Journal of Vascular Surgery
|September 15, 2012
Summary
The Zenith Dissection Endovascular System, used with the PETTICOAT technique for aortic dissection, has a risk of stent misalignment. Despite this, no serious clinical issues were reported in a 50-month follow-up.
Area of Science:
- Vascular Surgery
- Endovascular Interventions
- Medical Device Technology
Background:
- The Zenith Dissection Endovascular System is employed for treating aortic type B dissection.
- The Provisional ExTension to Induce COmplete ATtachment (PETTICOAT) technique is utilized with this device.
Observation:
- A potential risk of stent misalignment exists due to the device's low radial force and lack of columnar support.
- This misalignment was observed in 4 out of 25 patients treated since 2005.
- Potential causes include excessive manipulation during implantation or subsequent procedures.
Findings:
- The manufacturer has revised the device design to mitigate misalignment risks.
- No severe clinical consequences related to stent misalignment have been documented.
- Mean follow-up duration was 50 months.
Implications:
- Continued vigilance in catheter manipulation post-deployment is crucial.
- Thorough review of postoperative imaging is essential for patient safety.
- Device design modifications aim to enhance procedural safety and efficacy.