MitraClip Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Transcatheter Mitral Valve Repair (TEER) · First cleared Jul 2014 · 17 device variants grouped
Total Reports
18,874
Reports (30d)
201
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Leaflet Tear with Single Leaflet Attachment
grade degenerative, delays reported, significant delays, presented grade, grade mixed
147
reports
Gripper Malfunction During Clip Deployment
sgc, delays reported, significant delays, grade functional, presented grade
121
reports
Clip Stability Issue Post-Deployment
regurgitation grade, performed treat, inserted deployed, xtw inserted, deployed mitral
82
reports
Single Leaflet Device Attachment with Recurrence
slda clip, longer attached, grade functional, presented grade, clip single
58
reports
Clip Deployment Failure During Procedure
regurgitation grade, performed treat, inserted deployed, treat functional, deployed mitral
51
reports
Literature Batch: M-TEER Stroke Volume Outcomes
article, included study, patients, edge, included
40
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Afterload Mismatch After MitraClip Implantation: Intraoperative Assessment and Prognostic Implications
Siddarth Jogani, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2020
Citations indexed from PubMed.
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