CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
1,156
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Stenosis After Long-Term Implant
condition, explanted implant, duration years, severe stenosis, explanted
2
reports
Registry-Based Device Explant Notification
devices, patient registry, implant patient, registry, registry registry
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,673 reports
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
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data