ABBOTT VASCULAR INC. · Transcatheter Mitral Valve Repair (TEER) · First cleared Jul 2014 · 17 device variants grouped
Total Reports
17,746
Reports (30d)
241
Active Signals
13
Open Recalls
3
Detection
Regulatory
Sep 8, 2022 · Open, Classified
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Sep 8, 2022 · Open, Classified
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Sep 8, 2022 · Open, Classified
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
Evidence
Recurrent Mitral Regurgitation After MitraClip: Predictive Factors, Morphology, and Clinical Implication
Atsushi Sugiura, et al. · Circulation Cardiovascular Interventions · 2022
Impact of mitral regurgitation aetiology on MitraClip outcomes: the MitraSwiss registry
Daniel Sürder, et al. · EuroIntervention · 2020
An updated meta-analysis of MitraClip versus surgery for mitral regurgitation
Nicholas Oh, et al. · Annals of Cardiothoracic Surgery · 2021
Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation and Response to MitraClip in the COAPT Trial
Zachary M. Gertz, et al. · Circulation Cardiovascular Interventions · 2021
Mitral Valve Transcatheter Edge-to-Edge Repair Using MitraClip or PASCAL
L. Schneider, et al. · JACC: Cardiovascular Interventions · 2022
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. 13 active signals detected right now.
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