Gore Septal Occluder Adverse Events: FDA MAUDE Data
W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Aug 2006
Total Reports
155
Reports (30d)
0
Active Signals
0
Open Recalls
11
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion During Deployment
implanted gore, asd occluder, doing, cardioform asd, physician implanted
3
reports
Swollen Disc Prior to Implantation
corresponding, talisman, amplatzer talisman, article, patients
1
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
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
Systemic Allergic Contact Dermatitis Due to a GORE CARDIOFORM Septal Occluder Device
Charles D. Resor, et al. · JACC Case Reports · 2020
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
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
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
Citations indexed from PubMed.
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