W. L. Gore & Associates, Inc. · Transcatheter Septal Occluder (ASD/PFO) · First cleared Aug 2006
Total Reports
145
Reports (30d)
2
Active Signals
1
Open Recalls
11
What the reports describe · Claripulse analysis
Device Embolization During Implant
foramen, pfo, gore cardioform, patent, cardioform
3
reports
Literature Batch: PFO Closure Long-Term Outcomes
pfo closure, pfo, included study, patients, included
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Feasibility and safety of a new generation of gore septal occluder device in children.
Lombardi M, et al. · 2016
Initial clinical experience with the GORE septal occluder for the treatment of atrial septal defects and patent foramen ovale.
Freixa X, et al. · 2013
The Gore Septal Occluder (GSO) for Multiple Indications in Children - An Intention to Treat Analysis.
Kumar V, et al. · 2021
Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1-Year Results from a Single-Center Experience.
Verolino G, et al. · 2023
Citations indexed from PubMed.
Keep exploring
MitraClip
ABBOTT VASCULAR INC. · 17,746 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,096 reports
Evolut FX
MEDTRONIC, INC. · 11,918 reports
Evolut PRO
MEDTRONIC, INC. · 7,401 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,040 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,236 reports
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
