ZILVER PTX DRUG ELUTING PERIPHERAL STENT UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ZILVER PTX DRUG ELUTING PERIPHERAL STENT UNKNOWN manufactured by Cook Ireland Ltd.

MAUDE Entry Details

Report Number3001845648-2020-00175
MDR Report Key9903867
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-03
Date Mfgr Received2020-03-16
Date Added to Maude2020-03-31
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 ContactMS. HEATHER RYAN
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Manufacturer G1COOK IRELAND LTD
Manufacturer StreetO HALLORAN ROAD NATIONAL TECHNOLOGY PARK
Manufacturer CityLIMERICK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZILVER PTX DRUG ELUTING PERIPHERAL STENT
Generic NameNIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Product CodeNIU
Date Received2020-03-31
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK IRELAND LTD
Manufacturer AddressO HALLORAN ROAD LIMERICK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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