NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP M003EZAS30210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-18 for NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP M003EZAS30210 manufactured by Stryker Neurovascular Cork.

MAUDE Entry Details

Report Number3008881809-2019-00350
MDR Report Key9339588
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-18
Date of Report2019-11-18
Date of Event2019-10-31
Date Mfgr Received2019-11-04
Device Manufacturer Date2019-03-27
Date Added to Maude2019-11-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TARA LOPEZ
Manufacturer Street47900 BAYSIDE PARKWAY
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone5104132500
Manufacturer G1STRYKER NEUROVASCULAR CORK
Manufacturer StreetIDA INDUSTRIAL ESTATE MODEL FARM ROAD
Manufacturer CityCORK NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP
Generic NameSTENT, INTRACRANIAL NEUROVASCULAR
Product CodeNJE
Date Received2019-11-18
Catalog NumberM003EZAS30210
Lot Number21333203
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER NEUROVASCULAR CORK
Manufacturer AddressIDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA NA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-18

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