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COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET Adverse Event — Injury (MDR 3002808486-2020-00454)

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET Adverse Event — Injury (MDR 3002808486-2020-00454) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; Generic name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR; Manu

DeviceCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Generic nameDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
ManufacturerWILLIAM COOK EUROPE
Report number3002808486-2020-00454
Event typeInjury
Product problemY
Date received2020-04-27
Report sourceCONSUMER
NarrativeINVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: PULMONARY EMBOLISM (PE), FRACTURED STRUT, VENA CAVA (VC) PERFORATION, OCCLUDED VESSEL, DEEP VEIN THROMBOSIS (DVT), INFERIOR VENA CAVA (IVC) STENOSIS/FIBROSIS, MIGRATION, TILT, DISCOMFORT, BILATERAL LOWER EXTREMITY AMPUTATION, LIMITED ACTIVITY . THE REPORTED ALLEGATIONS HAVE BEEN FURT
SourceopenFDA MAUDE (device adverse events)

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