ZILVER PTX 35 DRUG-ELUTING STENT G38483 ZISV6-35-125-6-140-PTX

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 2020-03-26 for ZILVER PTX 35 DRUG-ELUTING STENT G38483 ZISV6-35-125-6-140-PTX manufactured by Cook Ireland Ltd.

MAUDE Entry Details

Report Number3001845648-2020-00167
MDR Report Key9883936
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-02-27
Date of Event2020-02-27
Date Facility Aware2020-02-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2020-01-13
Date Added to Maude2020-03-26
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 35 DRUG-ELUTING STENT
Generic NameNIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Product CodeNIU
Date Received2020-03-26
Model NumberG38483
Catalog NumberZISV6-35-125-6-140-PTX
Lot NumberC1698997
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 2020-03-26

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