MitraClip Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Transcatheter Mitral Valve Repair (TEER) · First cleared Jul 2014 · 17 device variants grouped
Total Reports
18,673
Reports (30d)
219
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Gripper Malfunction During Clip Deployment
regurgitation mitraclip, sgc, grade functional, delay reported, procedure clinically
168
reports
Chordal Rupture During Leaflet Grasping
grade degenerative, regurgitation mitraclip, degenerative mitral, mitraclip successfully, prolapsed
125
reports
Clip Opening Failure Post-Deployment
performed treat, treat, xtw inserted, inserted, deployed mitral
65
reports
Clip Opening Failure During Placement Attempt
regurgitation grade, performed treat, inserted, treat functional, deployed mitral
53
reports
Literature Batch: M-TEER Stroke Volume Outcomes
age, article, patients, study, included
29
reports
Clip Replacement Due to EFAA Failure
clip replaced, grade functional, procedure clip, test, angle efaa
13
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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
Related research
Complications Following MitraClip Implantation
Katharina Schnitzler, et al. · Current Cardiology Reports · 2021
Recurrent Mitral Regurgitation After MitraClip: Predictive Factors, Morphology, and Clinical Implication
Atsushi Sugiura, et al. · Circulation Cardiovascular Interventions · 2022
Mitral valve surgery after a failed MitraClip procedure
Francesco Melillo, et al. · Interactive Cardiovascular and Thoracic Surgery · 2020
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
Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure
Blanca Trejo‐Velasco, et al. · Journal of Clinical Medicine · 2021
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,682 reports
Evolut FX
MEDTRONIC, INC. · 13,277 reports
Evolut PRO
MEDTRONIC, INC. · 7,758 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,164 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,432 reports
WATCHMAN
BOSTON SCIENTIFIC CORPORATION · 3,844 reports
Want automated safety signal detection?
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.
Get Early AccessUnderstanding this data