Gore Septal Occluder Adverse Events: FDA MAUDE Data
W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Aug 2006
Total Reports
161
Reports (30d)
5
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion During Deployment
implanted gore, disc thickness, asd occluder, cardioform asd, physician implanted
5
reports
Left Disc Deformation During Implant
amplatzer septal, chosen implant, amplatzer, occluder chosen, chosen
1
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
Dec 14, 2022 · Open, Classified
Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
Sep 21, 2022 · Open, Classified
Due to manufacturing records (Release Test Results) indicating "Failed".
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Sep 2, 2021 · Open, Classified
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Evidence
Related research
Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1-Year Results from a Single-Center Experience
Giuseppe Verolino, et al. · Journal of Clinical Medicine · 2023
Multicenter midterm follow-up results using the gore septal occluder for atrial septal defect closure in pediatric patients.
Grohmann J, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2016
Initial clinical experience with the GORE septal occluder for the treatment of atrial septal defects and patent foramen ovale.
Freixa X, et al. · EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2013
The Gore Septal Occluder (GSO) for Multiple Indications in Children – An Intention to Treat Analysis
Vivek Kumar, et al. · Heart Lung and Circulation · 2021
Feasibility and safety of a new generation of gore septal occluder device in children.
Lombardi M, et al. · Journal of cardiovascular medicine (Hagerstown, Md.) · 2016
Citations indexed from PubMed.
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