ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared May 2019
Total Reports
375
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Literature Batch: TAVR Vascular Complications
valve, aortic, complications, proglide, prostyle
7
reports
Literature Batch: Vascular Closure Device Efficacy
closure devices, proglide, complications, vcd, plug
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
<scp>Real‐world</scp> experience of <scp>suture‐based</scp> closure devices: Insights from the <scp>FDA</scp> Manufacturer and User Facility Device Experience
Brian C. Case, et al. · Catheterization and Cardiovascular Interventions · 2021
Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.
Marcusohn E, et al. · 2022
Comparison of ProGlide vs. Prostar in patients undergoing transcatheter aortic valve implantation.
Giordano A, et al. · 2019
Vascular complications of ProGlide versus Prostar in transcatheter aortic valve replacement (TAVR) procedures: meta-analysis.
Xiang Y, et al. · 2023
Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry
Sérgio Berti, et al. · Journal of the American Heart Association · 2020
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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