StarClose SE Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Apr 2018 · 2 device variants grouped

Total Reports

988

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Suture Break During Knot Advancement

provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Evidence

Related research

Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database.

Johnson DT, et al. · Journal of vascular and interventional radiology : JVIR · 2013

Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients.

Spiliopoulos S, et al. · Diagnostic and interventional radiology (Ankara, Turkey) · 2016

Angioseal VIP® vs. StarClose SE® closure devices: a comparative analysis in non-cardiological procedures.

Lucatelli P, et al. · The Journal of cardiovascular surgery · 2013

Safety and efficacy of StarClose SE Vascular Closure System in high-risk liver interventional oncology patients.

Gaba RC, et al. · The journal of vascular access · 2012

Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures.

Cox T, et al. · Surgical technology international · 2015

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.