ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Apr 2018
Total Reports
892
Reports (30d)
13
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Clip Deployment Failure on Fat Tissue
reported clinically, arteriotomy closure, provided arteriotomy, delay procedure, artery using
20
reports
Literature Batch: TAVR Vascular Complications
valve, aortic, complications, proglide, prostyle
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Extravascular compared to Intravascular Femoral Closure is Associated with Less Bleeding and Similar MACE after Percutaneous Coronary Intervention.
Kim SH, et al. · 2019
Acute limb ischemia caused by incorrect deployment of a clip-based arterial closure device.
Dzieciuchowicz Ł, et al. · 2016
Differences of bleedings after percutaneous coronary intervention using femoral closure and radial compression devices.
Kim SH, et al. · 2019
Central Pseudo-Aneurysm Formation Following Arterial Closure with a StarClose SE Device: When a StarClose Doesn't Completely Close.
Memon S, et al. · 2016
Nitinol clip distal migration and resultant popliteo-tibial artery occlusion complicating access closure by the StarClose SE vascular closure system.
Choi DH, et al. · 2016
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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